Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-22

Study Completion Date

2021-07-03

Brief Summary

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This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.

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Detailed Description

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Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria defined by International Dental Federation (FDI).

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Single group with a split mouth design in which each subject received all three treatments. Of the 53 total subjects, 3 study subjects actually received duplicate treatment, i.e., they received 6 dental restorations.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Universal Composite

Supreme Universal Restorative

Group Type ACTIVE_COMPARATOR

Supreme Universal Restorative

Intervention Type DEVICE

Flowable Composite

Supreme Flowable Restorative

Group Type EXPERIMENTAL

Supreme Flowable Restorative

Intervention Type DEVICE

Bulk Fill Flowable Composite

Bulk Fill Flowable Restorative

Group Type EXPERIMENTAL

Bulk Fill Flowable Restorative

Intervention Type DEVICE

Interventions

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Supreme Universal Restorative

Intervention Type DEVICE

Supreme Flowable Restorative

Intervention Type DEVICE

Bulk Fill Flowable Restorative

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* must have given written informed consent to participate in the trial
* must need at least three posterior dental fillings
* replacement restorations due to caries or an esthetic replacement with or without caries are acceptable.
* must be available for the required post-operative follow-up visits
* restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure
* Class II restorations must have at least one proximal contact
* restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
* all restorations must Class II with a proximal contact with a natural or artificial tooth

* present with any systemic or local disorders that contra-indicate the dental procedures included in this study
* have an unstable occlusion
* have severe bruxing or clenching or in need of TMJ related therapy
* have teeth with periapical pathology or expected pulp exposures
* have teeth that are non-vital or that exhibit signs of pulpal pathology
* are pregnant.

Exclusion Criteria

* have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
* have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
* have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
* are unavailable for long term recall
* cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration.

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes