Evaluation of the success rate of indirect pulp capping treatment using

different materials: a clinical study

Naeima Betamar, Esra Borgeia, AbdulGafar Fareg

1. Introduction
The main objectives of the modern approach of restorative dentistry is to preserve
pulp health of caries teeth, thus reducing the need for root canal treatment and
preserve the teeth on the dental arch long-term. 1 Treatment of vital teeth with deep
carious lesions is challenging and varied among dental clinicians. Nowadays, based
on biological concept of treatment strategies along with the recent development of
bioactive dental materials; deep caries lesions treated with conservative and
minimally invasive approach, with selective caries removal techniques which is
recommended by recent agreement reports, that stated that the complete or
nonselective carious removal is considered overtreatment.2, 3
Indirect pulp capping
(IPC) treatment is a procedure generally used in deep cavity preparation, involves the
removal of all soft infected dentine with or without leaving behind a layer of caries
affected dentine remains in close proximity to the vital pulp, followed by application
of pulp capping material, and then restoration. 4, 5 It is a therapeutic intervention in the
treatment of vital teeth with deep carious lesions approximating the pulp with no signs
of pulp degeneration in order to avoid pulp exposure and therefore, preserve pulp
vitality.1, 5, 6
The idea behind using this technique based on the ability of the dental
pulp to develop inorganic mineralized dentine-like matrix as a part of the repair
mechanism in the dentine pulp complex.7-9 i.e. preserving the pulp biologic function to
stimulates and induce odontoblasts to produce tertiary dentine. 8 The objective of IPC
treatment is to discontinue demineralization of carious dentine and thus arresting the
carious progression by promoting remineralization and stimulating reparative dentine
formation.9
Several materials have been used and tested as pulp capping agent.8-15 Important
properties for pulp capping materials are biocompatibility and preserve pulp vitality,
antibacterial property, i.e. destroy and eradicate the remaining microorganisms
1
present in the vicinity of the pulp, thus prevent bacterial growth under restorations, as
well as neutralize acidic tissue resulting from the microorganisms byproducts in
carious defect.16 17
Able to promote tissue repair and healing, adhere to dentine and
restorative material as well as sealing capabilities. 8, 18 Among those materials calcium
hydroxide Ca(OH)2 which is introduced by Hermann in 1921 has been considered the
"gold standard" of direct and indirect pulp capping material for several decades. 17, 19 It
is available in several forms such as aqueous suspensions or as cements, liners, or
filled resins as visible light-cured liner containing calcium hydroxide. 17 For instance
(Dycal) is a Ca(OH)2 liner (Dentsply, Milford, DE, USA), self-cure radiopaque
material with an alkaline pH (pH 9–11).20 In clinical practice, it is the first material
applied as a liner in patients with deep cavities and remains the most popular material
among dentists.20
Calcium hydroxide-based materials are reported to display excellent antibacterial
properties and induce mineralization and reparative dentine formation because of their
chemical irritation nature.21, 22 Ca(OH)2 has the ability to release hydroxyl (OH) and
calcium (Ca) ions upon its dissociation into the surrounding environment. 17, 23, 24 These
ions caused chemical injury that stimulates the pulp to perform a defense mechanism
where the undifferentiated cells within the pulp differentiate into odontoblasts that
form a hard mineralized tissue as a reparative dentine. 21, 25 In addition, the hydroxyl
ions create an alkaline pH,20 that is unfavorable environment for remaining bacteria in
the cavity.17 However, the conventional two-paste chemical-cure formulation of
Ca(OH)2 cement has several disadvantages that may resulted in failure of the
treatment such as; it is highly soluble in oral fluids that lead to dissolution over time,
lack of adhesion to dentine as well as to resin-based restorative materials, and poor
sealing ability, internal resorption, extensive dentine formation obliterating the pulp
chamber, low elastic modulus and low compressive strength,4, 17, 20, 26 degradation after
acid etching and presence of tunnel defects through reparative dentine bridge. 4, 19, 20
Due to these drawbacks of chemical cure Ca(OH)2; a single component liner that
contains calcium hydroxide and is polymerized by visible light was introduced in
1988 to overcome the limitations of the chemical cure Ca(OH)2; they set on
command, improved strength, essentially no solubility in acid, and minimal solubility
in water.56 A visible light-cured calcium hydroxide liner consists of calcium

2
hydroxide and barium sulfate dispersed in a urethane dimethacrylate resin
containing initiators and accelerators activated by visible light. 27
Various other materials have been introduced into dental practice and used as pulp
capping agent such as glass ionomer/resin modified glass ionomer cements and
adhesives, and calcium-silicate materials (CSMs).2, 19
CSMs are recent bioactive
materials have the ability to induce regenerative responses in human body and form
hard tissue dentine bridge, superior in biocompatibility, and sealing of the pulp
capped site, and result in more predictable clinical outcomes. 12, 13, 19 An example of
these materials is mineral trioxide aggregate (MTA),19 that has gained excellent
reputation and commonly recommended and preferred by dentists.28, 29
The second
generation of these CSMs are; Biodentine and TheraCal LC.1, 2
Biodentine is new
bioactive tricalcium silicate-based cement, designed to be used as a permanent,
biocompatible dentine substitute and stimulates pulp cells to form tertiary dentine. 2, 30
TheraCal LC is a light-cured flowable resin-modified calcium silicate material
introduced by Bisco Inc. Schamburg, IL. USA in 2011, designed to overcome the
weaknesses of the previous generation such as poor bonding of CSMs to resins
restorations. It is used as direct and indirect pulp capping material that enables the
instant application of final restoration. 1, 2 TheraCal bond to deep moist dentine and
performs as barrier and protectant material of the pulp-dentine complex underneath
composite, amalgam, and cements.31 Hence, it acts as a replacement for Ca(OH)2,
glass ionomer, resin modified glass ionomers (RMGIs), and other pulp capping
materials.19 It contains polymerizable methacrylate monomers, Portland cement type
III, polyethylene glycol dimethacrylate, and barium zirconate. 32 The presence of the
tricalcium silicate particles in a hydrophilic monomer in TheraCal LC provides high
calcium release ability making it a stable and durable material as a liner or base.
Additionally, calcium release stimulates hydroxyapatite and secondary dentine bridge
formation. TheraCal displayed strong physical properties, high radiopacity and lower
solubility than either ProRoot MTA or Dycal. 1, 33 However, it is opaque and “whitish”
in color, which might adversely affecting the shade of composite restorations. 19 Yet,
the success of the pulp capping procedure greatly depends upon the circumstances
under which it is performed, along with proper pulpal diagnosis, control of caries
activity, placement of well-sealed restoration, patient motivation and good oral
hygiene,4, 15 as well as the partial or complete caries excavation.4, 34-36

3
 The aim of this clinical study was to evaluate the success rate and (along with)
clinical outcomes of indirect pulp capping treatment using three materials namely;
Dycal (chemical-cure calcium hydroxide), Biner LC (Light-cure calcium hydroxide),
and TheraCal LC (light-cure resin-modified calcium silicate) in permanent posterior
teeth with deep carious lesions.

Materials and Methods .2

Detailed descriptions and composition of materials used in the study are listed in
.Table 1

Please double chick of the composition of the materials (especially Dycal)(

Table 1: Description and composition of the materials used in the study

Material *Components Manufacturer
Dycal ® Ivory Base paste: calcium tungstate, tribasic calcium phosphate, Dentsply
Radiopaque calcium and zinc oxide in glycol salicylate. Catalyst paste: calcium
hydroxide hydroxide, zinc oxide, and zinc stearate in
ethylene toluenesulfonamide. Calcium tungstate or barium
sulfate fillers to provide radiopacity

Binar LC UDMA resin, calcium dihydroxide, dimethylaminoethyl- Voco GmbH,

Containing calcium methacrylate, and TEGDMA. Cuxhaven,
hydroxide Germany

TheraCal LC CaO, calcium silicate particles (type III Portland cement), Sr Bisco Inc.,
Light-curing resin-modified glass, fumed silica, barium sulphate, barium zirconate, and Schamburg,
calcium silicate filled liner resin containing Bis-GMA and PEGDMA IL, USA

FiltekTM Z250 XT, Surface-modified zirconia/silica 20 nm, fillers loading 82% 3M ESPE
Nanohybrid Resin by weight. BIS-GMA, UDMA, Bis-EMA, TEGDMA and
Composite PEGDMA.

Adper™ Single Bond 2 10% by weight 5nm colloidal silica nanofiller. Bis-GMA, 3M ESPE
dimethacrylates, ethanol, water, photoinitiator, polyacrylic
and polyitaconic acids, HEMA.
*According to manufacturers’ technique profiles: Bis-GMA: Bisphenol-A-glycidyldimethacrylate; UDMA: Urethane
dimethacrylate; Bis-EMA: Bisphenol A ethoxylate dimethacrylate; TEGDMA: Triethylene glycol dimethacrylate;
PEGDMA: HEMA; 2-hydroxyethyl methacrylate. CaO: calcium oxide

:Study design

A randomized clinical trial was conducted at Al-Raja Dental Clinic in Benghazi City.
A total number of 200 posterior permanent teeth with deep carious lesion indicated
for indirect pulp capping treatment from 130 adult patients were contributed in this
study. Ppermissions from the patients were obtained after giving a brief explanation

4
on the kind of investigation and the clinical procedure that was to be conducted.
Inclusion criteria included male and female patients ranging in age from 18 to 55
years old having premolars or molars teeth with deep carious lesion on the occlusal or
occluso-proximal surface (Class I and II cavity) without any pain or with very mild
sensitivity on cold or discomfort on chewing due to the presence of a carious hole.
Preoperative radiograph shows deep carious lesion extending into the inner dentine as
greater than two-third of dentine thickness approaching pulp,10 but with a definite
radiodense region between the deepest part of carious lesion and the pulp. 36 Teeth
with clinical symptoms of irreversible pulpitis, a history of spontaneous pulpal pain,
or pulp necrosis or with negative response to pulp tests, mobility, and tender on
percussion, presence of swelling or fistula as well as absence of clinical diagnosis of
pulp exposure were excluded from the study. In addition, radiographically; if teeth
show presence of periapical or furcation area radiolucency,10 periapical pathology,
internal or external root resorption, absence of normal appearance of periodontal
ligament, were also excluded from the study.

Clinical procedures

Thermal vitality test (cold test) was done to confirm tooth sensitivity; the response
quickly disappeared after the stimulus was eliminated. Preoperative periapical
radiograph was taken for each patient to assess penetration depth and the extent of the
lesion, as well as the thickness of the remaining dentine overlying the pulp chamber.
All the clinical procedures were performed by the standard method of IPC treatment
under rubber dam isolation by one operator. After clinical examination and
radiographic assessment of the tooth and carious lesion, local anaesthesia was
administrated. A sterile diamond bur suitable to the cavity's size in a high speed
handpiece was used to initiate cavity preparation and access carious lesion and
remove the undermined decayed enamel reaching caries dentine under constant water-
cooling to avoid heat generation. Caries was removed completely from the lateral
walls and cavosurface margins of the cavity preparation. Excavation of carious
dentine included complete removal of all wet, soft, necrotic and demineralized carious
tissue from the periphery to the center of the lesion; i.e. at first, the carious dentine
was removed from peripheral sites of the lesion and when reaching the central or the
deepest part of the lesion at the pulpal floor of the cavity, or at the axial wall (in case

5
of class II cavity) selective excavation of the caries was done included thoughtful
excavation of the wet and soft demineralized dentine upcoming a firm and well-
founded dentine with careful visual inspection along with tactile sensation to avoid
the risk of pulp exposure.
A hand instrument spoon excavator was used to remove necrotic fragments of caries
infected dentine followed by a round bur at low speed handpiece under water coolant.
A new sterile bur is replaced in the handpiece when approaching the deeper area of
the caries lesion to avoid introduction of infected dentine into the pulp during caries
excavation. The cavity was then washed with normal saline and gently air-dried.
Teeth were then randomly assigned into three groups (Gp:1, Gp:2, and Gp:3)
according to the material used for pulp capping. Gp1 consists of 67 teeth allocated to
receive treatment with Dycal (chemical-cured radiopaque calcium hydroxide) pulp
capping material. Dycal is available as two-paste system, a catalyst paste and a base
paste. It was mixed with equal quantities of both the catalyst and the base to a
homogenous paste and applied with dycal applicator directly over the deepest spots of
the dentine on the pulpal floor of the cavity. Excess of Dycal dressing material was
removed from the surrounding cavity walls and enamel margins. Gp 2 consists of 68
teeth and treated with Biner LC; Light-curing radiopaque one-component cavity liner
containing calcium hydroxide. It was applied into the deepest spots of the pulpal floor
of the cavity preparation and then light cured according to manufacturer instructions.
TheraCal LC (Light-curing, resin-modified calcium silicate filled liner) was applied in
Gp3 that have 65 teeth in a similar way as in Gp2. Both the Biner LC and TheraCal
LC are available as a single paste material in a syringe, thus each of these materials
was applied directly from the syringe into the desired deepest spots of cavity
preparation. Excess material was removed while still soft and before light curing the
material.
The randomization unit was the tooth, and the randomization procedure was
performed as follows. A number corresponding to each treatment group was printed
on pieces of paper and kept in dark flasks. A paper was selected from the flask by a
person other than the operator, and the treatment indicated was performed.37

The bonding and restorative procedures were performed for the three investigating
groups similarly as followed; The cavity walls and margins were acid etched with
37% phosphoric acid semi gel (Meta Biomed Co Ltd., Korea) for 30 seconds, then
thoroughly rinsed off with water and gently air-dried using compressed air to remove

6
excess water without desiccation. Bonding agent Adper™ Single Bond 2 Adhesive
(3M ESPE) was applied with a microbrush in two consecutive layers and then gently
air dries to allow evaporation of the solvent then light-cured for 10 seconds with LED
light curing unit (Mini LED, Satelec, France). For class II cavity preparation, a
Tofflimire retainer with a matrix band was placed before acid etching and ponding
procedures. Nanohybrid resin composite restorative material FiltekTM Z250 XT (3M
ESPE) was incrementally packed in the cavity preparation. Each increment was
polymerized for 20s using LED light curing unit (Mini LED, Satelec, France). After
completing the restoration, occlusal adjustment was done in maximum intercuspation
and eccentric movements. The identified high spots were carefully removed using
extra fine grit diamond burs EX-17EF, FO-23EF (Toboom Shanghai Precise Abrasive
Tool Co., Ltd) under water coolant, and then polished with polishing tips to eliminate
any surfaces scratches (Enhance Dentsply Caulk). After completing the treatment,
patient was instructed about preventive measures and maintenance of oral hygiene.
At follow-up examination, detailed clinical and radiographic examination was
performed for every patient after 2 months, 6 months, and at 1 year interval. Clinical
success of the treatment was defined as healthy pulp and principally assessing pulp
vitality of the treated tooth and evaluated by the following criteria: intact restoration,
positive (normal) response to thermal (cold) pulp test, absence of spontaneous pain,
no tenderness on percussion or palpation, no tooth mobility, abscess or swelling of
14, 37, 38
periodontal tissues of the treated tooth. On radiographic examination; success
of the treatment included intact lamina dura, no periapical radiolucency, no internal or
external root resorption.14, 38
Any tooth that presented symptoms or signs of
irreversible pulpitis or presented with any one of the above mentioned criteria at
clinical and/or radiographic evaluation was recorded as treatment failure and was root
canal treated. Restorative treatments and clinical and radiographic evaluations were
performed by the same operator.14
The data of the recorded findings were tabulated using Microsoft Word Excel sheet
and subjected to statistical analysis using the SPSS (version 11.5, SPSS Inc. IBM
Corp. Chicago, USA) software.

3. Results

7
A total of 200 experimental teeth with deep caries lesions restored with three pulp
capping materials and direct composite restorations were evaluated. Number of
Female patients was ….. account for ….. %, and number of male patients was …..
account for …..%. to male ratio was ….. Molars teeth accounted for 150 (75%) and
premolars accounted for 50 (25%). 80 teeth were in the maxilla and 70 in the
mandible (Table 1). Among those, 100 class I and 80 class II. One tooth was restored
at each clinical visit. 67 teeth treated with Dycal; number of molar teeth was ……,
number of premolar teeth was …….. 68 teeth treated with Biner LC; number of
premolars was ….. and molars are …… 65 teeth received TheraCal LC; number of
premolars …….. number of premolars ……

Statistical analysis revealed that there are no significant differences between the
three pulp capping treatment using three materials. The success rate of using Dycal
was ….% with only 2 cases failure that needed root canal treatment (RCT). Similar
results were obtained with Biner LC pulp capping treatment with a success rate of ….
%. On the other hand the success rate of TheraCal LC material, the success rate was
100% with no failure recorded in the treatment.

4. Discussion

5. Conclusions

6. References

1. Zaparde N, Gunda S, Patil A. TheraCal… Future of Pulp Capping??? . International J of

Development Research 2017;7(10):16338-42.
2. Marta. K, Lukomska-Szymanska M. Bio-Inductive Materials in Direct and Indirect
Pulp Capping—A Review Article. J Materials 2020;13, 1204:1-20.
3. Schwendicke F, Frencken JE, Bjørndal L, et al. Managing Carious Lesions: Consensus
Recommendations on Carious Tissue Removal Adv Dent Res 2016;28:58–67.
4. Hilton TJ. Keys to clinical success with pulp capping: a review of the literature. Oper
Dent 2009;34(5):615-25.
5. Costa CA, Hebling J, Hanks CT. Current status of pulp capping with dentin adhesive
systems: A review. Dent Mater 2000;16:188–97.

8
6. Thompson V, Craig RG, Curro FA, Green WS, Ship JA. Treatment of deep carious
lesions by complete excavation or partial removal: A critical review. J Am Dent Assoc
2008;139:705-12.
7. Accorinte MDLR, Holland R, Reis A, et al. Evaluation of mineral trioxide aggregate
and calcium hydroxide cement as pulp-capping agents in human teeth. Journal of
Endodontics 2008;34(1):1–6.
8. Bachoo IK, Seymour D, Brunton PA. Biocompatible and bioactive replacement for
dentine: is this a reality? The properties and uses of a novel calcium-based cement.
British Dental Journal 2013;214(2):E5.
9. Cao CY, Mei ML, Li QL, Lo ECM, Chu CH. Methods for biomimetic remineralization of
human dentine: A systematic review. Int J Mol Sci 2015;16:4615–27.
10. Gruythuysen RJ, van Strijp AJ, Wu MK. Long-term survival of indirect pulp treatment
performed in primary and permanent teeth with clinically diagnosed deep carious
lesions. J Endod 2010;36:1490-3.
11. Renata F, Luciano C, Alice SP, et al. Clinical and radiographic evaluation of indirect
pulp treatment in primary molars: 36 months follow-up. Am J Dent 2007;20(3):189-
92.
12. Hilton TJ, Ferracane JL, Mancl L. Comparison of CaOH with MTA for Direct Pulp
Capping: A PBRN Randomized Clinical Trial. J Dent Res 2013;92:S16–S22.
13. Gandolfi MG, Siboni F, Botero T, et al. Calcium silicate and calcium hydroxide
materials for pulp capping: Biointeractivity, porosity, solubility and bioactivity of
current formulations. J Appl Biomater Funct Mater 2015;13:41–60.
14. Gurcan AT, Seymen F. Clinical and radiographic evaluation of indirect pulp capping
with three different materials: a 2-year follow-up study. European Journal of
Paediatric Dentistry 2019;20(2):105-10.
15. Lucia CD, Raluca D, Levente GC. Clinical and radiographic evaluation of indirect pulp
capping with MTA and calcium hydroxide for permanent teeth. Romanian Journal of
Medical and Dental Education 2019;8(3):35-45.
16. Neelakantan P, Rao CV, Indramohan J. Bacteriology of deep carious lesions
underneath amalgam restorations with different pulp-capping materials - an in vivo
analysis. J Appl Oral Sci 2012;20 139-45.
17. Arandi N. Calcium hydroxide liners: a literature review. Clinical, Cosmetic and
Investigational Dentistry 2017; 9:67–72.
18. Mantellini MG, Botero TM, Yaman P, et al. Adhesive resin induces apoptosis and
cellcycle arrest of pulp cells. Journal of Dental Research 2003;82(8):592–96.
19. Qureshi A, Soujanya E, kumar N, kumar P, Shivarao S. Recent Advances in Pulp
Capping Materials: An Overview. Journal of Clinical and Diagnostic Research
2014;8(1):316-21.
20. Cox CF, Subay RK, Ostro E, Suzuki S, Suzuki SH. Tunnel defects in dentin bridges:
Their formation following direct pulp capping. Oper Dent 1996;21(1):4-11.
21. Almushayt A, Narayanan K, Zaki AE, George A. Dentin matrix protein 1 induces
cytodifferentiation of dental pulp stem cells into odontoblasts. Gene Therapy
2006;13(7):611–20.
22. Nosrat A, Peimani A, Asgary S. A preliminary report on histological outcome of
pulpotomy with endodontic biomaterials vs calcium hydroxide. Restorative Dentistry
& Endodontics 2013;38(4):227–33.
23. Mohammadi Z, Dummer PMH. Properties and applications of calcium hydroxide in
endodontics and dental traumatology. International Endodontic J 2011;44(8):697–
730.

9
24. Fulzele P, Baliga S, Thosar N, Pradhan D. Evaluation of calcium ion, hydroxyl ion
release and pH levels in various calcium hydroxide based intracanal medicaments:
an in vitro study. Contemporary Clinical Dentistry 2011;2(4):291– 95.
25. Laurent P, Camps J, About I. Biodentine(TM) induces TGF-β1 release from human
pulp cells and early dental pulp mineralization. International Endodontic Journal
2012;45(5):439–48.
26. Schuurs AH, Gruythuysen RJ, Wesselinde PR. Pulp capping with Resin based
composite versus calcium hydroxide: A review endodontics. Dental Trauma
2000;16:240-50.
27. Sakaguchi RL, Powers JM. Craig’s Restorative Dental Materials. Philadephia, PA:
Elsevier/Mosby; 2012.
28. Dominguez MS, Witherspoon DE, Gutmann JL, Opperman LA. Histological and
scanning electron microscopy assessment of various vital pulp-therapy materials.
Journal of Endodontics 2003;29(5):324-33.
29. Malik G, Bogra P, Singh S, Samra RK. Comparative evaluation of intracanal sealing
ability of mineral trioxide aggregate and glass ionomer cement: an in vitro study.
Journal of Conservative Dentistry 2013;16(6):540–45.
30. Laurent P, Camps J, de Méo M, Déjou J, About I. Induction of specific cell resonses to
a Ca3SiO5-based posterior restorative material. Dent Mater 2008;24(11):1486-94.
31. BISCO. Seal and Protect with TheraCal LC Pulp Capping Material and Liner [internet].
[Consultado 2014 17]. Disponible en: https://www.bisco.com/assets/1/18/MC-
51160BD.pdf.
32. Hebling J, Lessa FCR, Nogueira I, de Carvalho RM, de Costa CAS. Cytotoxicity of resin
based light-cured liners The American Journal of Dentistry 2009;22(3):137–42.
33. Gandolfi MG, Siboni F, Prati C. Chemical-physical properties of TheraCal, a novel
light-curable MTA-like material for pulp capping. Int Endod J 2012;45(6):571-79.
34. Thompson V, Craig R, Curro F, Green W, Ship J. Treatment of deep carious lesions by
complete excavation or partial removal. . Journal of the American Dental Association
2008;139:705–12.
35. Maltz M, Oliveira E, Fontanella V, Carminatti G. Deep caries lesions after incomplete
dentine caries removal: 40-month follow-up study. Caries Research 2007;41:493–96.
36. Bjørndal L, Fransson H, Bruun G, et al. Randomized Clinical Trials on Deep Carious
Lesions: 5-Year Follow-up. J Dent Res 2017;96(7):747-53.
37. Maltz M, Garcia R, Jardim JJ, et al. Randomized Trial of Partial vs. Stepwise Caries
Removal: 3-year Follow-up. J Dent Res 2012;91(11):1026-31.
38. Venkatesh Babu NS, Kavyashree BS, Amitha HA. Comparative Assessment of Success
Rate of Indirect Pulp Treatment With 2% Chlorhexidine Gluconate Disinfecting
Solution, Calcium Hydroxide And Resin Modified Glass Ionomer Liner In Primary
Teeth - A Prospective Study. Journal of Dental and Medical Sciences 2018;17(1):68-
77.

10