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

University of North Carolina (UNC)

Status: Terminated

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

Treatments: Device: Filtek Supreme Ultra; Device: Filtek Bulk Fill Posterior

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02572570

14-3097

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be 18 years of age and older
• Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
• Be capable of giving written informed consent.

Exclusion criteria

• Have a self-reported history of any adverse reaction to materials of the types to be evaluated
• Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Posterior Composite Resin Restoration

Experimental group

Description:

Participants will receive two commercially available tooth-colored restorative materials used for direct restoration as per manufacturer's instructions.

Treatment:

Device: Filtek Bulk Fill Posterior

Device: Filtek Supreme Ultra