NCT02572570

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-12-05
• Completion: 2019-12-05
• First posted: 2015-10-09
• Last updated: 2020-12-19
• Results posted: 2020-12-19

Locations

1 site across 1 country: United States