Evaluation of implant designs & materials used in maxillofacial prosthesis

CONTENTS

1. INTRODUCTION
2. ROLE OF OSSEOINTEGRATION IN MAXILLOFACIAL PROSTHESIS
3. IMPLANT RETAINED PROSTHESIS VERSUS ADHESIVE RETAINED PROSTHESIS.
4. DISADVANTAGES OF ADHESIVE RETAINED MAXILLOFACIAL PROSTHESIS.
5. IMPLANT DESIGN CONSIDERATIONS IN THE RECONSTRUCTION OF VARIOUS MAXILLOFACIAL DEFECTS.
a. Orbital defects.
b. Nasal defects.
c. Auricular defects.
- Bone Anchored Hearing Aids (BAHA)
d. Midface Defects.
e. Maxillary defects.
f. Mandibular defects.
6. HISTORICAL DEVELOPMENT OF MAXILLOFACIAL MATERIALS
7. CHARACTERISTICS OF AN IDEAL MAXILLOFACIAL MATERIAL.
8. VINYL POLYMERS AND COPOLYMERS
9. ACRYLIC RESINS.
10. LATEXES.
11. SILICONES.
a. Room Temperature vulcanizing silicones.
b. Heat vulcanizing silicones.
12. POLYURETHANE ELASTOMERS.
13. COMMERCIALLY AVAILABLE NEWER MATERIALS.
14. PIGMENTS AND THEIR APPLICATION IN MAXILLOFACIAL PROSTHESIS.
15. ADHESIVES.
16. SUMMARY AND CONCLUSION
17. REFERENCES.

1
INTRODUCTION

Congenital or acquired defects of the oral and maxillofacial region are accompanied by dysfunction and disfigurement
and produces significant modalities and unique tissue management problems. If the esthetic and functional impairments are not
corrected or minimized, the patient may be unable to resume a normal life. Maxillofacial prosthesis is the important tool used in
the rehabilitation of these defects. However, appropriate retention, stability and support must be provided to the prosthesis if
successful results are to be achieved. Osseointegrated implants have been shown to be the most useful asset in the retention,
stability and support when compared to other conventional prosthesis.

One of the most challenging tasks that polymer chemist, material scientists and maxillofacial prosthodontist face is the
development of a suitable, durable and esthetic material to use in the rehabilitation of patients with orofacial disfigurements. A
durable and stable material that will retain the characteristics of living tissue, such as colour, softness, flexibility and tear
resistance and should be available at reasonable cost should be used in the construction of maxillofacial prosthesis.

Definition of Maxillofacial Prosthesis:

“Maxillofacial prosthesis is defined as the branch of prosthodontics concerned with the restoration, replacement or
both stomatognathic and associated facial structures by artificial substitutes that may or may not be removed. It encompasses
prosthetic rehabilitation of patients with oral, paraoral or facial defects, which may be acquired (developmental or congenital) or
resulting from disease or trauma”.

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Osseointegration in Maxillofacial Prosthesis:

The prosthodontic restoration of dental-alveolar and maxillofacial defects has significantly improved with the
development of new materials and advances in clinical, surgical and laboratory techniques. These advances specifically the use of
endosseous implants have improved retention, stability and esthetics, resulting in more natural appearing and functioning
prosthesis.

The term osseointegration is defined as a “direct structural and functional connection between ordered, living bone and
the surface of a load-carrying implant”.

Over the years, procedures have been developed in which titanium retention elements have been integrated in the
bone tissue close to the defect, thus providing anchorage for the prosthesis through mechanical or magnetic retention.

The concept of surface area, force and stress distribution are of significant concern with the implant retained facial
prosthesis. Bone in the temporal, orbital and midface regions is seldom adequate for placement of implants designed for
maxillofacial use.

The predominant limiting factor for maxillofacial impression is a decrease in the bone thickness.

The craniofacial implants are fabricated of commercially pure titanium and they are short about 3-5mm in length and
possess a peripheral flange that is about 5mm in diameter. The flange increases implant surface area in contact with the bone,
perforations in the flange add additional surface area and provide mechanical stabilization and prevents undue penetration into
the inferior compartment.

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 A two stage surgical procedure, basically the same as that used in the intraoral application is employed. Surgical
placement can be conducted with local anesthesia. The implant sites are prepared and tapped in the usual manner.

Implant Retained Prosthesis Versus Adhesive Retained Maxillofacial Prosthesis:

The major development in recent years has been the use of osseointegrated implants for retention. The use of
osseointegrated implants is destined to have dramatic impact on restoration of facial defects. The retention and support derived
from these implants eliminates some of the primary limitations of adhesive retained facial restorations.

1. Improved retention and stability of the prosthesis.

2. Elimination of occasional skin reaction to adhesives.

3. Ease and advanced accuracy of prosthesis placement.

4. Improved skin hygiene and patient comfort.

5. Decreased daily maintenance associated with removal and reapplication of skin adhesives.

6. Increased life span of the facial restoration when skin adhesives are used for retention, they must be removed reapplied
daily, leading to loss of colourants at the margin of the prosthesis.

7. Enhanced lines of juncture between the prosthesis and skin when an implant-retained prosthesis is fabricated, its
margins can be made thinner and positive pressure developed with the prosthesis.

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Disadvantages of Adhesives used in the Retention of Maxillofacial Prosthesis:

1. The adhesive retained prosthesis requires daily removal of the adhesive, which may damage the extrinsic colors of the
facial surface and may eventually result in margin loss.

2. Adhesives tend to damage prosthesis margin gradually with daily use and may tend to loose adhesive bond if
perspiration present.

3. Adhesives will leads to an allergic skin reaction if used for longer time.

4. Silicon adhesives require silicone solvent for cleaning, which may cause deterioration of base material.

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Implant Designs used in the Reconstruction of Orbital Defects:

Restoration of an orbital defect presents a special problem. The normal eye moves constantly, whereas the artificial eye
is fixed, the eyelid does not move and gaze does not change direction.

The application of implants in orbital defects reduces the need for adhesives and enables easy application and removal
of the prosthesis.

Problems associated with adhesives in the temporal region are more prevalent in the orbit. The blind duct
characteristics of an orbital defect combined with the margin sealing using adhesives enhance moisture accumulation behind the
prosthesis. Chronic moisture accumulation on the skin is characterized by marked inflammation, affecting the health of soft
tissues. This inflammation may cause discomfort and adversely affects the fit and esthetic quality of the prosthesis. Extra oral
implants can provide support and retention for orbital prosthesis, that are far superior to those achieved with skin adhesives.

For an orbital prosthesis, the implants are ideally placed around the defect within the orbital rim. Because of the bone
anatomy placement is often limited to the superior and lateral aspects of the rim. The implants should be placed within the
confines of the defect and parallel or slightly inward in relation to the frontal plane, so as not to interfere with the ideal contours
of the prosthesis.

In more extensive orbital defects, implants can be placed in the zygoma or maxilla.

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Various Retention Options:

In the orbital defects basically five retention options used:

1. Bar end clips.

2. Bar and magnets.

3. Individual magnets.

4. Ball attachments.

5. Combination of these.

Bar Construction with Retentive Clips:

A bar construction is a wire soldered to the gold cylinders and mounted onto the abutments by gold screws. This type of
attachment will provide a good load distribution on the implants. Retentive clips are placed on the inner aspect of the acrylic
plate, providing a rigid and secure position for the prosthesis. This type of construction provides good retention for large defects
that has implants only in the upper orbital rim to support the prosthesis.

Individual Magnets:

The individual retention system consists of a magnet cap that is threaded onto the abutment and a magnet placed into
the fitting side of the prosthesis. In an orbital defect with implants in the upper and lower orbital rim the individual magnet
system is recommended. This type is especially recommended when there is shallow defect with insufficient space for a bar and
clip construction.

Advantages:

1. Easy for patients to maintain good hygiene around the abutments.

2. Easy to put on and take off the prosthesis.

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Ball Attachments:

When there is shallow defect, the ball attachments are one opinion of retention because they occupy little space behind
the prosthesis. Three implants creating tripod are imperative to provide satisfactory retention and stability.

Console Abutment:

In cases with small closed defects where two implants are inserted in the upper rim and one exists in the lower orbital
rim and where the directions of implants are at difficult to angles to each other, prosthetic abutment options are improved by
the use of a console abutment. This device can alter the angle of one fixature relative to another thereby facilitating prosthesis
attachment.

Case Reports:

1. A 71 year old man underwent a left orbital exenteration due to adenocarcinoma of the lacrimal gland. Four implants
were placed in the orbital rim. Individual magnets placed on to the abutments retained the prosthesis.

2. Photographs showing a woman with right orbital defect, which was due rhabdomyosarcoma. The surgery was done
when patient was at the age of 15 years. She had several prosthesis retained using glasses and adhesives but none of

8
them were esthetically and functionally satisfying to the patient. Eventually three implants were placed in the orbital
rim, providing mechanical retention for the prosthesis with a gold bar and clip.

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 3. Photograph showing a lady who had a successful prosthesis ranging from hard acrylic retained by spectacles through
direct adhesive fixation when offered osseointegration she was very keen. Three Neo-mini magnets are retained using
three implants on supraorbital rim.

Implant Designs used in Reconstruction of Nasal Defects:

Nasomaxillary or Nasolabial defects cause functional and esthetic problems, which may require load-bearing capability
by the fixture sites especially lip forces dislodge the prosthesis.

Implants to anchor a nasal prosthesis can be placed in the maxillary and frontal bones. The placement of implants
should be within the confines of the outer contours of the prosthesis. Location of the frontal sinuses and the superior margin of
the prosthesis are limiting factors in the placement of implants in the superior aspect of the defect. If the implants are placed
within the inferior aspect of the defect, care must be taken so that access is available for retentive components.

Case Reports:

1) A 57 year old female had the entire nasal tip and approximately 50% nasal bridge as well as part of the alar
cartilages removed to eliminate squamous cell carcinoma. Nasal prosthesis, which was fabricated failed to be adequately
secured using an adhesive.

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 The patient was treated with two 10mm dental implants placed into approximately 3mm into the anterior maxilla
through the nasal fossa.

A cast gold bar was fabricated to connect the implant abutments. Magnetic attachments were cast into the superior and
inferior aspects of the gold bar and clip attachments were fabricated to fit into the middle portion of the gold bar. A resin housing
retained by undercuts in the silicone prosthesis secured magnetic and clip attachments. Magnets assist the patient in orienting
the prosthesis while clip attachments provide definite retention.

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2) A 70 year old woman underwent an excessive nasal resection due to recurrent squamous cell carcinoma
involving the nasal tip, septum and the right cheek. Two implants were placed in the maxillary bone. A gold bar was
fabricated to splint the two fixtures so that silicone prosthesis could be mechanically retained by gold clips.

3) A 75 year old woman underwent a rhinectomy due to basal cell carcinoma. Three implants were placed into
the nasal remnant and maxilla. At second stage surgery, abutments were connected on to the fixatures. A gold bar was
attached to the abutments, and gold clip retention was used for silicone prosthesis.

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Implant Designs used in the Reconstruction of Auricular Defects:

For an auricular prosthesis, implants are placed in the post-auricular region. This area corresponds to the location of
helix and antihelix.

Tjellstrom and his associates described that the location of implants should be 18-20mm from the center of the external
auditory meatus.

For an auricular prosthesis, two to three implants are normally sufficient for satisfactory retention and the ideal position
is approximately 20mm from the center of the external auditory canal. This position will helps in the construction of bar in
proper contour with antihelix ridge to enable the anaplastologist to make a prosthesis that is deep enough to produce a good
cosmetic result.

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Retention Systems or Attachments:

Two retention systems are used separately or combined.

1. Use of a gold alloy bar approximately 2mm in diameter, which is soldered to the gold cylinders and attached to the
abutments. Retention clips are incorporated into the prosthesis providing attachment to the bar.

2. Retention technique by use of magnets.

Gold alloy bars may be fabricated to retain the magnets, which are connected to the abutments. Magnets are
commonly 6mm in diameter and 2mm in thickness. The bar structure must be designed to contain housing to hold
magnets, which are sealed into acrylic resin.

Case Reports:

1. Photographs of a young woman underwent multiple procedures for right auricular reconstruction of a microtia. The
patient history indicated that a silicone elastomeric framework had been used in the reconstruction of the auricle. The
results were unacceptable to the patient, who elected to undergo reconstruction with the bone-anchored auricular
prosthesis. The silicone elastomer framework was removed, and the tissue bed in area of prosthesis was recontoured.
Two implants were placed to retain the prosthesis on a bar and clip system.

2. Photographs showing selected prosthetic steps for rehabilitation of a left auriculectomy due to squamous cell
carcinoma. Initially, the prosthesis was anchored on two fixtures, but the final results were not satisfactory because of
the gap on the front edge. To provide larger base plate, three more fixatures were used. Magnets were used instead of a
bar for easier cleaning of the prosthesis. The baseplate was split and sprung to keep the front edge in contact with the
skin and reduce stress on the implants.

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Bone Anchored Hearing Aids (BAHA):

Impaired hearing makes it difficult for many people to successfully cope with important aspects of their daily life. More
than 10 years of experience in Sweden has demonstrated the usefulness of the osseointegrated bone anchored hearing aid. Two
groups of patients are typically good candidates for osseointegrated bone anchored procedures; patients with external auditory
canal atresia, who are not candidates for reconstructive surgery of the canal and middle ear and patients with chronic otitis
media who cannot or will not tolerate an air conduction aid.

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Why is the bone anchored hearing aid (BAHA) different?

We receive sound in two ways: by air conduction via the ear canal and by bone conduction transmitted through the jaws
and skull bone.

Air conduction aids, which are placed inside the ear canal or behind the ear, are the most familiar. Some hearing
impaired people are unable to use this kind of device. Some suffer from chronic inflammation or infection of the ear canal made
worse when the ear canal is occluded.

The BAHA system uses the principle of osseointegration to overcome these problems. A small titanium screw is
implanted behind the ear where it osseointegrates.

Indications:

1. Chronic otitis media with conductive or mixed hearing loss where the use of an air conduction device is contraindicated.

2. Congenital malformation of the external/middle ear where an air conduction hearing aid is contraindicated.

3. Patients suffering from chronically draining ears and who uses an AC device.

4. Patients with chronic external otitis.

5. Patients who have a bone conduction pure-tone average of 45dB or less and speech descrimination of 60% or greater.

Contraindications:

1. Contraindicated in patients with drug and alcohol addiction.

2. Emotionally unstable and developmentally delayed or retarded patients for the reason of handling and hygiene.

Procedure:

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 A one-stage surgical procedure under local anesthesia allows placement of the titanium implant and abutment in the
mastoid cortex. Removal of hair follicles from the skin immediately surrounding the abutment or placement of a split-thickness
skin graft is critical to maintain a hair-free region around the abutments. After osseointegration, the abutment is loaded with the
mechanoelectric transducer system.

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Various Bone Anchored Hearing Aids:

BAHA classic 300 is available in two colours, light and dark. It is presented as a patient kit including the hearing aid, four
plastic inserts, five ‘O’ rings mounting instruments, battery and abutment cover.

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Surgical components:

All fixtures and cover screws are made of pure titanium:

Flange fixtures 3.75 x 3mm

Flange fixtures 3.75 x 4mm

Implant Designs used in the Reconstruction of Midface Defects:

Midface defects often result from ablative procedures used to control malignancies of nasal and maxillary structures.
The surgeries may produce a small soft tissue defect or a massive defect involving intraoral and extraoral structures. As the size
of the defect expands to involve the intraoral structures, the muscles of facial expression, and the muscles of mastication, the
complexity of the prosthetic rehabilitation increases.

Defects which involve palatal and extraoral structures are frequently retained by connecting the intraoral and extraoral
prosthesis together. This process involves the use of adhesives combined with the magnetic retention between the two
prosthesis. This technique enhances retention for the facial prosthesis but may adversely affects its stability. Movement of the
intraoral prosthesis is transferred to the facial prosthesis producing a noticeable and unnatural appearance. Removal of either
prosthesis may adversely affect the retention of other requiring it also to be removed. As with orbital and auricular prosthesis,
rehabilitation in the midface region with the endosseous implants will enhance retention, stability and esthetic of the prosthesis.

Jenson D.T. et al (1992) described available sites for implant placement in the midfacial region, and they suggested a
craniofacial site classification for osseointegrated implants

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 1. Alpha sites: These are 6mm or greater in axial bone volume available for dental implants. The most common areas of
the facial skeleton having that much bone available are the anterior maxilla through the nasal fossa and the zygoma and
the zygomatic arch and the lateral periorbital region.

2. Beta sites: These will have 4 to 5 mm of bone available permitting the use of 4mm craniofacial implant. These areas are
superior, lateral and inferolateral orbital rims as well as much of the temporal bone and zygoma.

3. Delta sites: These are marginal sites with 3mm or less of bone volume available. Locations in the temporal bone,
pyriform rim, infraorbital rim, nasal bone, zygomatic buttress and zygomatic arch require the use of 3mm craniofacial
implants.

Case Reports:

1) A 58 year old male had a 10 years of history of adenocystic carcinoma of the midface with early metastasis to
the right lung. Definitive excision of the midfacial lesion included radical rhinectomy, 90% of total maxillectomy complete
upper labilectomy, and bilateral partial malarectomies.

Treatment of the patient was followed by reducing the right and left zygoma by about 50% and two 18mm implants
were placed into molar bone bilaterally using the curve of the zygomatic arch and one implant was placed in the zygomatic area,
where 4-5mm of bone was available. After 6 months implants were exposed and 5.5mm abutments were placed.

Gold bar was fabricated on each side to allow for clip attachments. Magnetic attachments were positioned on the facial
surface of the maxillary obturator.

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2) A 77 year old man underwent wide resection for a basal cell carcinoma, which included left orbital
extenteration and partial left nasal resection. Four implants were placed into the supraorbital rim and maxillary area. At the
second stage procedure, console abutments were connected to the four implants, providing magnetic retention for the final
prosthesis.

3) A 61 year old woman underwent an enbloc resection of the nose and anterior maxilla due to squamous cell
carcinoma. Five implants were placed in the alveolar ridge to retain obturator and one implant was placed in the nasal bone
to anchor a nasal prosthesis. The intraoral and extraoral frameworks were attached by a connection system with screws and
screw nuts.

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4) The photograph showing surgical defect involving nose and cheek, which was operated due to basal cell
carcinoma. A nasal prosthesis extended to include, cheek defect was given to the patient with adhesives. On review of 10
months later, the margins of the prosthesis were damaged during cleaning the adhesives from the prosthesis. The
osseointegrated implant retained prosthesis was discussed with the patient. Three implants were subsequently placed, one
on each of alar extensions and one at the lateral margins of the cheek. A 5mm abutment was fitted with right alar implant
and 4mm abutments were fitted on other two implants.

Implant Design Considerations in Maxillectomy Defects:

Most tumors requiring maxillary resection arise either from the paranasal sinus or palatal epithelium or from the minor salivary
glands present in the submucosa. Resection of these tumors requires either a radical or a total maxillectomy.

Prosthetic rehabilitation in maxillectomy should not only provide closure between the oral and nasal cavity but also substitute for
teeth and support for the upper lip and the anterior soft tissues of the face. Since most of the skeletal components for anchorage
have been removed at surgery and the anchorage should be obtained from zygoma and in the pterygoid region.

Implant Design Considerations Mandibular Defects:

The management of malignant tumors associated with the tongue, the mandible and adjacent structures represent a challenge
for the surgeon and prosthodontist, with respect to control of the primary disease and rehabilitation after the treatment. The
most common intraoral sites for squamous cell carcinoma are the lateral margin of the tongue and floor of the mouth. Both

22
locations predispose the mandible to the invasion of tumor, often necessitating its resection along with large portions of the
tongue, the floor of the mouth, and the regional lymphatics.

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HISTORICAL DEVELOPMENT OF MAXILLOFACIAL MATERIALS

Even before dentistry attained its status as a profession, some surgeons had recognized the limitations inherent in
grafting tissue for repair of certain maxillofacial deficiencies and had argued the use of prosthesis as an alternate method.

1. Early records indicate that artificial eyes, ears and noses were found in Egyptian mummies. The Chinese also made facial
restorations with waxes and resins of various types.

2. Ambroise Pare (1517-1590), the famous French surgeon appears to be the first medical writer on maxillofacial
prosthetic materials. He recommended a prosthetic nose, which could be made of silver and attached to the face by
strings, with the line of junction at the lip being camouflaged by an artificial moustache.

3. Tycho Brahe, a Danish astronomer of the 16 th century, lost his nose in a duel and replaced it with an artificial nose made
of silver and gold.

4. Pierre Fauchard (1678-1761) described that the wings that could be positioned by the patient from the oral side of the
obturator and made use of the nose for retention.

5. The London Medical Gazette (1832) described a case of the “Gunner with the silver mask”. A French soldier whose face
was seriously injured in the battle. The left half of the mandible almost carried away, alveolar process was fractured,
along with the teeth of the left maxilla and right half of the mandible. A physician designed a prosthetic restoration,
which was looked like a mask.

6. William Morton (1868) constructed a nasal prosthesis using porcelain for a Boston lady whose nose was lost due to
malignant disease. The prosthesis was attached to spectacles.

7. Tetamore (1894) described and illustrated nine cases of nasal deformities, that were treated by nasal prosthesis which
were made of “very light plastic material”, that approximated the natural colour. They were secured on the face by bow
spectacles.

8. Towards the end of nineteenth century, vulcanite having already proved its value in prosthodontics, it replaced most of
the earlier materials such as cellulose acetate, ceramic and metals.

9. In Germany (1913) the gelatin-glycerin compounds attracted much attention. The material was easy to compound and
simple to manipulate, and one that possessed pliability translucency, and adaptability of intrinsic colouring to match the
skin.

10. The most significant contribution of the prevulcanized latex era was that it provided the impetus in the early 1930s to
further research towards the desirable qualities of latex.

11. Bulbulian and Clarke (1965) introduced prevulcanized latex in the construction of maxillofacial prosthesis.

12. Fonder and Winnetka (1955) presented an article titled “Dental materials and skills in oral and maxillofacial prosthesis”.
They used acrylic resin for fabrication of cleft palate, missing ears, noses and other missing parts of the face.

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 13. Lontz J.F. (1990) described the use of most of the general biomedical materials like acrylic polymers, polyurethanes, and
silicone elastomers in the fabrication of various maxillofacial prosthesis.

Characteristics of an Ideal Maxillofacial Material:

1) Material should have physical and mechanical properties similar to the human tissue being replaced.

a) Variable consistency.

b) Dimensional stability.

c) Allow detail reproduction.

d) High edge strength.

e) High elasticity.

f) Light weight.

2) Material must be compatible with the human tissue, non-toxic, non allergic and easily cleaned.

a) Non-porous but permeable.

b) Odorless.

c) Resistant to microbial contamination.

d) Should not release any toxic byproducts; no toxic components to harm operator.

3) Material must be capable of adherence to human tissue, by adhesive or other mechanical means:

a) Should permit easy removal of adhesive without damage to the patient or material.

b) Material must be sufficiently strong to incorporate frameworks for implant or other mechanical
retention.

4) Material must be compatible with intrinsic and extrinsic means of colouring or staining.

a) Capable of layering in the mold for depth and vitality in colouring.

b) Translucency, surface texture and should have sheen consistent with tissue.

c) Should permit extrinsic colouring without modifying surface characterization.

5) Material should have relatively simple polymerization process, not sensitive to minor processing variables, and
require materials and molding procedures commonly used in dentistry.

a) Capable of adjustments, repair and reline.

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 b) Can be bonded or laminated to other materials for better properties.

c) Modified at margins.

d) Readily available at reasonable cost.

6) Completed prosthesis must maintain these properties for an acceptable period of service (at least 1 year).

- Prosthesis must have an acceptable service life of at least 1 and preferably 5 years.

- Material must be capable of relining or readapting to the tissues surrounding the defect to prolong service life.

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Vinyl Polymers and Copolymers:

The most widely used materials for the fabrication of maxillofacial prosthesis are vinyl polymers and copolymers. The amount of
vinyl acetate in the polymer varies from 5-20%. In the elastomeric form, when properly compounded, the vinyls exhibit
properties, which are superior to those of natural rubber in flexibility and resistance to sunlight and aging.

The vinyl are derivatives of ethylene (CH2 = CH2)

H H
| |
C = C
| |
H H
The vinyl acetate
H H
| |
C = C
| |
H C =O
|
H – C – H

Vinyl chloride is polymerized in the presence of free radical catalyst to form polyvinyl chloride:

H H H H H H
| | | | | |
–C –C – C – C – C – C –
| | | | | |
H Cl H Cl H Cl

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Vinyl acetate forms polyvinyl acetate on polymerization:
H H H H
| | | | | |
–C –C – C – C – C – C –
| | | | | |
H O H O O
| | |
C=O C=O C=O
| | |
CH3 CH3 CH3
Polyvinyl chloride is a clear, hard and odourless resin. It darkens when exposed to ultraviolet light and heat, and it
requires heat and light stabilization to prevent discoloration during fabrication and use.

Polyvinyl acetate is stable to light and heat but has an abnormally low softening point (35°-40°C).

Physical properties Flexible vinyl Rigid vinyl

Specific gravity 1.16-1.35 1.35-1.45

Tensile strength 1,500-3.500 5,000-9,000

Compressive strength 9,00 – 1,700 8,000-13,000

Impact strength Ft.lb/inch Varies depending on plasticizer 0.4-20

Thermal conduction 10-4 cal/sec (°C) 3.0-4.0 3.0-7.0

Water absorption (24 hrs %) 0.15-0.75 0.07-0.4

These materials were extensively used in the beginning but their use decreased due to the various factors like excessive
shrinkage, long processing time, discoloration and hardening of the margins due to plasticizer migration and loss. They absorb
sebaceous secretions and tend to get soiled due to their tackyness.

Realistic:

Realistic is a polyvinyl chloride compound (PVC) which solidifies into a flexible material when heated materials of this
chemical composition are subject to deterioration by UV light, ozone, peroxide and tetraethyl lead. These materials are
esthetically satisfactory, but possess a short shelf life.

Realistic is extremely easy to handle. Tinting can be accomplished both internally and externally using a variety of
colouring agents. Ferrous pigments incorporated into the mixture give the longest shelf life and the best esthetic results. Because
of the short life of this material, metal molds are suggested so that additional prosthesis can be made from original modeling.

Mediplas:

It is a heat curing plastisol that is basically a polyvinyl organic compound. These are available in a variety of premixed
base colours, which can be further tinted to match the patient’s skin tones.

Like all the polyvinyl resins, this product is affected by ultraviolet light, peroxide, ozone and tetraethyl lead. The
substrate is changed and the prosthesis become yellow when exposed to these factors.

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 In processing these materials, an initial set is obtained at 100°C, but the material does not reach full strength until the
temperature reaches 140°C. About 10 min at 140°C is generally required for polymerization of mediplas in an plaster or metal
mold.

Fine margins can be produced with mediplas, except that these margins are unsupported, they tear easily. An insert of
white nylon stocking material will strengthen them.

Acrylic Resins:

Acrylic resins are used in the fabrication of both intraoral and extra oral prosthesis. The acrylic resins are derivatives of
ethylene and these contain vinyl group in their structural formula. These are obtained from acids CH=CHCOOH, and methacrylic
acids CH2 = C (CH) 3 COOH. Both of these acids polymerize by additional polymerization. Although the polyacids are hard and
transparent, their polarity related to the carboxyl group, causes them to be soluble in water. The water tends to separate chains
and to cause a general softening and loss of strength.

Methyl methacrylate:

Methyl methacrylate is a clear, transparent liquid at room temperature with melting point of –54.4°F (-48°C), boiling
point 100.8°C, density of 0.445 gram/cubic centimeter and heat of polymerization of 12.0 kilocalories / molecule. It exhibits a
high vapour pressure, and it is an excellent organic solvent. The polymerization can be initiated by UV light or heat and chemical
initiators.

Advantages:

1. These can be satisfactorily coloured to match individual skin tone. The tinting/colouring can be done internally and
externally. To prevent the external tinting from wearing off, a thin coat of clear organic acrylic is painted over the surface
of external staining.

2. These materials are preferred for restoring defects that require minimal movements like eye and ear prosthesis.

3. These materials can also be of value with rapidly changing defects, where the ease of relining facilitates all the
necessary abutments.

4. These materials are easily available and have less cost and are familiar to all the practitioners.

Disadvantages:

1. The main complain incurred by the patient is the rigid nature of the material. Prosthesis with rigid margin will tends to
dislodge the prosthesis and irritates the underlying structures.

2. The rigid property will leads to difficulty in duplicating the prosthesis.

Latexes:

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 These are soft, inexpensive materials that may be used to create life like prosthesis. Unfortunately, these materials are
weak, degenerate rapidly and exhibit colour instability. Consequently, latexes are infrequently used in the fabrication of
maxillofacial prosthesis.

Synthetic latex is a tripolymer of butyl acetate, methyl methacrylate and methyl methacrylamide. These are superior to
natural latex. This material is nearly transparent. Colorants are sprayed onto the reverse or tissue side of the prosthesis, there by
providing enhanced translucency and improved blending. Despite these advantages, technical process is lengthy and resultant
prosthesis last only a few months.

Silicones:

Silicones were introduced around 1946, but only in the past few years they have been used in the fabrication of
maxillofacial prosthesis.

These are most commonly used materials for facial restorations but properties like poor tear strength and life less
appearance have limited them from universal acceptance.

Silicones are a combination of organic or inorganic compounds. They are manufactured from silica. Silica is first reduced
to silicon and then it reacted with metal chloride to form dimethyl-dichloro-siloxane. Dimethyl-dichloro-siloxane reacts with
water to form a polymer, which is a translucent, white watery fluid. Polydimethyl siloxane commonly referred to as a silicone,
which is made from these fluid polymeris.

Commercially available rubber form polymers have fillers for additional strength. Antioxidants and vulcanizing agents
are added to transform the raw mass into a rubbery resin during processing. “The process of crosslinking the silicone is known as
vulcanizing”.

Depending on the means used to activate the vulcanizing process, silicones are classified as heat vulcanizing and room
temperature vulcanizing silicones.

Room Temperature Vulcanizing Silicones:

RTV silicones are composed of comparatively short chains; together with cross-linking agent (ethyl ortho silicate) with
the addition of a catalyst (stannous octolate), condensation takes place between the polymer and cross-linking agents.

These materials are either transparent or opaque white, and before the catalyst is introduced, dry earth pigments are
added to match the colour of the individual skin. The prosthesis can be cured in a stone mold.

RTV silicone formulated with silica fillers to enhance tensile strength and to mask yellowing or discoloration sacrifice.
Considerable translucency, making it difficult to attain proper internal (intrinsic) colouration. Discoloration in some RTV grades of
silicone compromises esthetics.

To correct for these deficiencies, a transparent RTV grade silicone (Dowcorning MDX 4-4210) is an improved alternative
but requires considerably longer curing time of upto 16 hours. The curing time can be reduced by heating upto 150°C for as little
as 5 minutes. The improvement in tear resistance is significant.

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 RTV silicones are supplied as a single paste systems that are coloured by the addition of dyed rayon fibres, dry earth
pigments and / or paints.

Heat Vulcanizing Silicones:

HTV silicones are supplied as semisolid or putty like materials, which require milling, packing under pressure, and a 30-
minute heat application cycle at 180°C, pigments are milled into these materials. As a result of intrinsic colouration HTV silicones
display better strength and colour stability compared to RTV silicones.

Chalion (1976) and Lontz, Schweiger, and Burger (1974) had found that HTV is superior compared to RTV. A major
advantage of this material is the faster colouring procedure, which is generally entirely intrinsic and polychromatic. Its major
disadvantage is the requirement for milling machine and a press. Metal molds are required for the fabrication, because high
tensile strength of HTV silicones is such that there is a high risk of damaging the mold during retrival.

Heat Vulcanizing Silicone Technique:

- Heat vulcanizing silicones are translucent, milky white, semisolid materials. Dow corning had made three
consistencies available: MDX4 – 4514, MDX4 – 4515, MDX4 – 4516.

- Chalion et al 1972; Beder 1974; Lontz et al 1974 recommended MDX4-4514 as a material of choice for extraoral
prosthesis.

- These silicones are cut and rolled in the milling machine before they are packed in the molds. Intrinsic colours
and fibers are incorporated with HTV while it is being rolled in the milling machine.

Room Temperature Vulcanizing Silicone Technique:

Dow Corning manufactures different kinds of RTV silicones. They are either clear or translucent MDX4-4210,
semitransparent, such as silastic 399; or opaque and white such as silastic 382. The differences among these RTV are in their
curing time and strength.

Silastic 399:

It resembles white vasaline in its raw state, applied with base and two catalysts. When mixing with catalyst, the cross
linking agent becomes somewhat milky, but it can be worked for several hours, when catalyst two is added it set upto translucent
rubber in 10-15 minutes.

Silastic 382 RTV:

It is a medical grade silicone. This product is in the form of a thick, white liquid and comes with a separate container of
an organometallic catalyst, which when combines with silicone, vulcanizes without the use of heat or pressure. The working time
varied from 2 to 6 minutes depending on the amount of catalyst.

Silastics-6508:

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 In the raw state it is similar to sticky modeling clay. It must be vulcanized at 260°F and formed in pressure molds. It
requires much more sophisticated handling.

Silphenylene

Silphenylene is an analene silicone polymer. It is synthesized and formulated as a pourable, viscous, RTV liquid. The
material consists of 3-unit kit, the base resin, tetrapropoxy silicone (cross linking agent) and a catalyst. This elastomer has high
tensile strength and low modulus of elasticity. It feels like skin. Recent studies indicate that the incorporation of modified filler
may substantially improve the tear strength.

Derma sil:

It is a self-curing silicone, clear base material and catalyst is used to initiate the reaction. Pigments are added to this to
obtain proper shade. The material become dull in appearance, it an excess pigment is used. The margins are quite fragile and
should be reinforce with nylon stocking material.

Polyurethane Elastomers:

Polyurethane is the most recent addition to the materials used in the maxillofacial prosthetics. These are characterized
by the linkage or presence of urethane.

These elastomers are synthetic proportions of long chain linear polyesters or polyethers reacted with diisocynates.
These can be thermoplastic or thermosetting polymer systems.

Components:

1. Hard segments – Extended diisocynates.

2. Soft segments – Polyesters and inolyanates.

3. Catalyst – Stannous octate or dibutylin diacirate.

4. Colouring agents – Inorganic colourants are specially preferred.

These elastomer when properly processed, are chemically inert resistant to solvents and ozone, odourless, abrasion
resistant have high tear and tensile strength, require the use of plasticizers to attain or control their flexibility.

These materials do not harden with wear and are dimensionally stable when processed. They can be coloured easily,
internally and externally.

Commercially Available Newer Materials:

Newer materials representing a variety of polymer classes offering unique characteristics have recently been made
commercially available:

1. Acrylic resin copolymer – Palamed Kulzer.

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 2. Vinyl polymers and copolymers – Realistic – Prosthetic Services, Calif.

Mediplast – Standard arts, Butler.

3. Polyurethane elastomers – Epithane-3 Daro products, Butler.

4. Silicone elastomers (RTV and HTV) – MDX4-4210, Silastic-372, 373

Dow corning mich.

Cosmosil – Principality UK (HTV)

Elastosil M3500 Waker/chemic (RTV)

Episil – Dentamid (RTV)

Silskin 2000 Dupery Health Care (RTV)

Dow Corning MDX4-4210:

It is a very useful silicone, but problems with the viscosity of these materials are a major problem, which can be
controlled by addition of silk in thickening agent. The cosmesil colour system also works very well with these materials. This
material is recommended, where soft silicone is required. The degree of softness may be varied by the addition or reduction of
the percentage of catalyst added.

Another colour system is popularly used with MDX-4-4210 is the range of ferrosilicone pastes and cosmetic pigments

Palamed:

Chemically Palamed is a cross-linked copolymer of methacrylics and acrylics, and its molecular structure causes it to
have an inherent softener. It consists of a liquid and a powder which when combined, form dough like material. This material is
packed into the close molds and cured in a hot water bath. When processed, the prosthesis has sponge like center and a
continuous skin like covering proper packing of the molds is critical in obtaining satisfactory final prosthesis.

The molds are underfilled by 10% to permit expansion material and formation of the foam like center. It is necessary to
use exact weight equivalent to palamed-to modeling materials.

Epithane:

Epithane is a polyurethane system. The various components which epithane consists are:

a. Polyol components (mixture of polyesters).

b. Diicynate components.

c. An organic catalyst.

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 Generally, these materials produce prosthesis, which are soft and more flexible, which can be obtained by increasing
ratio of polyol components to diisocynate in vulcanized mixture. The disadvantage of this polyurethane is deteriotion of
prosthesis and occasional skin irritation.

Cosmesil/ Silskin-2:

Cosmesil is a heat vulcanizing silicone and silskin-2 is a room temperature vulcanizing silicone. These are available in
elastomer and colour systems.

The curing temperature for cosmesil is 70°C for 2 hours; Silskin-2 is cured by heat (1 hour) or 24 hours under bench
press.

Pigments and their Application in Maxillofacial Prosthesis:

Duplicating skin with respect to texture, contour, and above all colouring is very difficult. Colour occupies an extremely
important position, and every effort must be made to duplicate normal skin color so that the prosthesis will look realistic.

Skin colors vary in different physiologic and pathologic conditions, such as anemia, an indifferent emotional state, which
may lead to pallor or flushing. The color depends on capillary blood flow and oxygenation, the thickness of epidermis, and the
presence of pigments such as melanin and carotene.

Carl J.A. et al (1992) conducted a survey to analyze the effect of environmental factors on maxillofacial elastomers. They
reported various intrinsic and extrinsic pigments for colouring the prosthesis.

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Intrinsic colouring Extrinsic colouring
- Dry earth pigments - Dry earth pigments.
- Rayon fibers - Artists oils.
- Artist’s oils. - Silicone paste.
- Kaolin. - Ferro paste.
- Silicon paste. - MDX-4-4210
- Ferro paste. - Dyes.
- Artists acrylic latex. - Tatoo
- Cosmesil pigments. - Water colours
- Dermafil pigments

John J.G. et al (1998) reviewed the pigments used silicone elastomers.

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Intrinsic colouring:

According to Chalian et al (1972, 1974) intrinsic colouring in HTV silicone prosthesis is accomplished with a milling
machine.

Metallic oxides or pigmented silicone concentrates are generally used, and red fibers may be incorporated to simulate
blood vessels.

Intrinsic colouring in RTV silicone (MDX-4-4210), which is supplied as a transparent viscous material is accomplished by
adding talk, to make the material opaque, and various dry earth pigments are added.

For accurate measurements, these pigments are mixed with RTV thinner in the ratio of 3 grains of pigment to 10ml of
RTV thinner, and stored in a small bottle with a dropper.

Extrinsic colouring:

1) Bartlett, Pineda and Moore (1971) recommended extrinsic colouring of maxillofacial prosthesis using medical adhesive-
silicone type A medical adhesive has been thinned with xylene, a small amount of it is placed in a number of individual
medicine cusp, each cusp is tinted with selected inorganic pigments, and the adhesive is then applied to the surface
with cotton swab. Skin like texture can be achieved by dabbing a patch of lint free gauze over the area.

2) Ouellete (1969) described spray colouring of silicone maxillofacial prosthesis, pigments selected to match the patient’s
skin are mixed in proportion with clear elastomer and solvent. The mixture was sprayed on the prosthesis until the
desired hue obtained. The catalyst spray is applied over the sprayed pigment solution and curing was done at 50°C for
five minutes.

3) According to Schaaf (1970), the colour peels off or rubs off during manipulation of the prosthesis or during daily
cleansing. He stated that additional layer of material obliterates the surface texture of the prosthesis. He introduced
tattooing for surface characterization using standard artists oil paints, which were applied on the surface of prosthesis
using tattooing machine.

4) According to Chalian et al (1972) and Beder (1974), the intrinsic colouration is more effective than the extrinsic
techniques because it produces longer casting results. Intrinsic colouration some times followed by minimal
characterization is helpful for achieving skin like colour.

5) Firtell and Bartlett (1969) and Roberts (1971) suggested that, in many cases, the basic tone of the prosthesis should be
made of a lighter colour. Lighter basic tone can be obtained by intrinsic coloring of the prosthesis and that should be
followed by minimal surface characterization according to needs of a given patient.

ADHESIVES:

Historically, facial prosthesis has been retained with various mechanical devices. It is now widely accepted that most
patients may be served by the use of suitable adhesive for retaining facial prosthesis.

36
 A number of adhesives are available and these are generally polymeric compounds that have been modified with
solvents and tackifying fluids. Selection of adhesive is based on the biocompatibility, retention properties and ease of
applicability and removal on daily basis and the nature of the material from which the prosthesis is fabricated.

Udagama (1975) reported that Biface adhesive tape is suitable for polyvinyl chloride resin: Davol may be used with
polyvinyl chloride and polyurethane. Medico adehsive may be used with polyvinyl chloride, silicone and acrylic and epithane-3
adhesive works well with both polyvinyl chloride and silicone.

INSTRUCTIONS TO THE PATIENTS:

- Patient should be encouraged to avoid prolonged exposure to sunlight and to use brimmed hats and
sunglasses.

- Instruct to avoid cosmetics on the prosthesis.

- Patient should avoid smoking, which will cause staining of the nasal prosthesis.

- Once a day the prosthesis should be taken off and the adhesive should not be removed using gentle thumb
pressure.

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SUMMARY AND CONCLUSION:

The highly successful results have been obtained with the implant retained maxillofacial prosthesis. The use of
osseointegration in maxillofacial prosthodontics overcomes the many limitations associated with conventional prosthesis. This
will continue a revolution in maxillofacial rehabilitation.

The maxillofacial materials currently available still do not meet patient needs. The possibility of fabricating high quality
life like prosthesis on the facial region would require a perfect material comprising of all the required properties of an ideal
material.

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