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Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth

NCT02572570 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-12-19

Study results available
· View outcomes & findings →

Summary

Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.

Conditions

  • Dental Restoration Failure of Marginal Integrity
  • Dental Caries
  • Unrepairable Overhanging of Dental Restorative Materials
  • Poor Aesthetics of Existing Restoration
  • Secondary Dental Caries Associated With Failed or Defective Dental Restorations
  • Fractured Dental Restorative Materials Without Loss of Materials
  • Fracture of Dental Restorative Materials With Loss of Material

Interventions

DEVICE

Filtek Bulk Fill Posterior

Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.

DEVICE

Filtek Supreme Ultra

Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.

Sponsors & Collaborators

  • 3M ESPE

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Rick Walter, DDS · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-12-05
Completion
2019-12-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02572570 on ClinicalTrials.gov