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

Solventum US LLC

Status: Completed

Conditions: Dental Caries

Treatments: Device: Bulk Fill Flowable Restorative; Device: Supreme Universal Restorative; Device: Supreme Flowable Restorative

Study type: Interventional

Funder types: Industry

Identifiers

NCT02889835

CR16-005

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 53 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

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.
• do not meet all inclusion criteria
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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53 participants in 3 patient groups

Universal Composite

Active Comparator group

Description:

Supreme Universal Restorative

Treatment:

Device: Supreme Universal Restorative

Flowable Composite

Experimental group

Description:

Supreme Flowable Restorative

Treatment:

Device: Supreme Flowable Restorative

Bulk Fill Flowable Composite

Experimental group

Description:

Bulk Fill Flowable Restorative

Treatment:

Device: Bulk Fill Flowable Restorative