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

NCT02889835 | Completed Results

• 1 other identifier: CR16-005
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

Class II; molar and premolar; resin composite; adult; restoration

Outcome Measures

Primary Outcomes (1)

• Percent Acceptable Restorations

  Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.

  36 Months

Secondary Outcomes (12)

• Surface Luster

  36 Month

• Surface Staining

  36 Month

• Color Match

  36 Month

• Fracture of Material and Retention

  36 Month

• Occlusal Wear - Qualitative

  36 Month

Study Arms (3)

Universal Composite

ACTIVE COMPARATOR

Supreme Universal Restorative

Device: Supreme Universal Restorative

Flowable Composite

EXPERIMENTAL

Supreme Flowable Restorative

Device: Supreme Flowable Restorative

Bulk Fill Flowable Composite

EXPERIMENTAL

Bulk Fill Flowable Restorative

Device: Bulk Fill Flowable Restorative

Interventions

Supreme Universal Restorative DEVICE

Universal Composite

Supreme Flowable Restorative DEVICE

Flowable Composite

Bulk Fill Flowable Restorative DEVICE

Bulk Fill Flowable Composite

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

University of Alabama at Birmingham Dental School

Birmingham, Alabama, 35233-2005, United States

Location

MeSH Terms

Conditions

Dental Caries; Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Nathaniel Lawson DMD PhD
• Organization: UAB School of Dentistry

nlawson@uab.edu

205-975-8302

Study Officials

• Nathaniel Lawson, DDS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: September 7, 2016
• Study Start: March 22, 2016
• Primary Completion: July 3, 2021
• Study Completion: July 3, 2021
• Last Updated: October 1, 2024
• Results First Posted: September 11, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)