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2021, 20:25 Clinical Evaluation of Posterior Indirect Resin Composite Restorations With PBE - ClinicalKey

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CLINICAL TRIAL  

Evaluation of Clinical Performance and Periodontal Status

of Posterior Indirect Resin Composite (Nexco) Restorations
With Proximal Box Elevation Technique: A Prospective
Controlled Clinical Trial up to 3 Years
First received on January 29, 2019.
Last updated on April 29, 2020.

Purpose
Evaluation of posterior indirect resin composite restorations with proximal box elevation
technique.
Restoration of large posterior defects extending below the cemento-enamel junction (CEJ) with
coverage
of one or more cusps represent a very common clinical situation. When restoring deep
cervical margins
biological and technical operative problems may occur. In order to make
clinical procedures less fault-
prone 'Proximal Box Elevation' (PBE) is an option that refers
to application of composite resin in the
deepest parts of the proximal areas in order to
reposition the cervical margin supragingivally prior to
cavity preparation for an indirect
restoration.
This project aims to evaluate the clinical performance and
periodontal status of posterior
indirect composite restorations with PBE. According to study design at
least 60 patients will
be recruited to project and 80 restorations will be evaluated. The project will be
carried
out at the School of Dentistry, Istanbul Medipol University,Turkey.

 
Status Recruiting

Condition Unsatisfactory or Defective Restoration of Tooth

Phase N/A

Study Interventional
Type

Official Evaluation of Clinical Performance and Periodontal Status of Posterior Indirect Resin
Title Composite (Nexco) Restorations With Proximal Box Elevation Technique: A Prospective
Controlled Clinical Trial up to 3 Years

Further study details (as provided by National Institutes of Health Clinical

Center (CC))

 
Enrollment 80

Start Date January 30, 2019

Detailed Description

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The rehabilitation of decayed or fractured posterior teeth using an indirect technique was
introduced for
large cavities with coverage of one or more cusps. Problems of biological
nature and technical operative
may be encountered when restoring large cavities extending
below the cement-enamel junction(CEJ).
Biological problems refers to the possible violation of the 'biological width', a recommended
distance of 3
mm or more between the restorative margins and the alveolar crest. The
technical operative problems
include difficulties in tooth preparation, impression making,
adhesive cementation of the restoration,
finishing and polishing in subgingival areas. In
order to eliminate these difficulties Proximal Box
Elevation' (PBE) was introduced that
proposes application of composite resin in the deepest parts of the
proximal areas in order
to reposition the cervical margin supragingivally. Whether the PBE technique is
the most
optimal treatment option for the restoration of cavities extending below CEJ and how the
proposed advantages and possible disadvantages could affect the clinical performance of the
indirect
restorations are the topics extensively discussed among clinicians.
According to results of in vitro
studies, PBE was found to be effective in indirect resin
composite bonding to deep proximal boxes in
terms of marginal quality and adaptation (1).
In a retrospective clinical study, 79 indirect composite
restorations were clinically
examined following modified United States Public Health Service criteria.
Survival rate was
91.1% and success rate was 84.8% after 5 years (2). Similarly, in another clinical study
success rate of 71 indirect composite restorations was reported as 100% after 36 months (3).
Nevertheless, not much scientific evidence on the influence of PBE technique on the longevity
of the
restorations and the periodontal health could be found in the currently available
literature. Randomized
controlled clinical trials with classification of baseline clinical
situation and standardization of cavity
preparations are necessary to evaluate the clinical
performance of this technique.
This study will be
carried out as a prospective study, with assessment of the restorations
after three years. 80 indirect
composite restorations in at least 60 patients will be
included. Potential patients attending to Istanbul
Medipol University Dental Clinics in
Istanbul will be invited to the study. The patients meeting the
inclusion criteria will be
recruited. After giving their consent to take part in the study, baseline clinical
situation
will be classified based on technical operative and biological parameters (4).
The treatment
procedure is:
Restorative process in all cases, will start with coronal relocation of the margins using
flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite
build-up.
Defined principles of morphology driven preparation technique will be followed for
standardization of
cavity preparations. Impression making, fabrication of indirect
restoration with SR Nexco and adhesive
cementation will be completed according to
manufacturer's instructions.
The control procedure is:
The
restorations will be evaluated according to marginal adaptation, cavo surface marginal
discoloration,
approximal contact, fractures and caries associated with restorations. The
periodontal status will be
assessed with defined periodontal parameters. The controls will be
conducted after two weeks, six
months, 1year, 2 and 3 years.

Eligibility

 
Minimum Age Eligible for Study: 18 Years

Maximum Age Eligible for Study: 60 Years

Genders Eligible for Study: All

Criteria

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Inclusion Criteria:
1. Vital or endodontically treated posterior teeth with extensive substance loss
2.
Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer)
3. Large posterior
defects with at least one or more cuspal coverage in molars
4. Proximal defects extending below CEJ and
at least one or more cavity margin/margins
located beneath the gingival tissues
5. Maximum 2 indirect
restorations with SR Nexco material in each patient
6. No obvious untreated caries in the rest of the
dentition, dental health problems
(regularly checked by a dentist)
7. Good or moderate oral hygiene
(plaque score of less than 30% in anterior region before
treatment)
8. No untreated periodontal disease
(only DPSI 1, 2)
9. Subjects had to be over 18 years of age, be classified according to the American
Society of Anesthesiologists (ASA) as ASA I or ASA II, present with moderate to good
oral hygiene, and
be free of periodontal disease (probing depth and attachment levels
within normal limits, no furcation
involvement, and no mobility)
10. Appropriate isolation after cavity preparations
11. Subjects had to
agree to keep the scheduled recall appointments for data collection
and maintenance and plan to stay in
the area for at least 3 years.
Exclusion Criteria:
1. Considerable horizontal and/or vertical mobility of
teeth: tooth mobility index score
2 or 3 2. Considerable periodontal disease without treatment (DPSI 3-,
3+ and 4)
2. Poor endodontic prognosis
3. Pulp exposure
4. Patients who still want to bleach their teeth
or bleached teeth less than 3 weeks ago
5. Extremely hypersensitive tooth
6. Excluding the teeth, without
opposing natural dentition (either intact or restored
with intracoronal or extracoronal fixed
restorations), and with a minimum of 20 teeth
7. Substance loss due to developmental anomalies
(hypoplasia, amelogenesis imperfecta
etc.)
8. Subjects who presented severe wear facets and/or reported
parafunctional activities
such as clenching or nocturnal bruxism
9. Subjects who are pregnant or breast
feeding during the duration of the study
10. Subjects who are known to be allergic to the ingredients of
resin materials

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03832829

Locations
Istanbul Medipol University, Dental School

 
Status: Recruiting

Facility: Istanbul, 34083, Turkey

Sponsors and Collaborators

Istanbul Medipol University Hospital

More Information

Other Publications

 
First Received: January 29, 2019

Last Updated: April 29, 2020

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ClinicalTrials.gov Identifier: NCT03832829

ClinicalTrials.gov processed this data on May 07, 2020

Link to the current ClinicalTrials.gov record.
(https://clinicaltrials.gov/show/NCT03832829)

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