Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Caries
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Number of participants with restoration failure of either material
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.
Detailed Description
In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.
Investigators
Adriana Cordero Wilson
Clinical Assistant Professor
Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria
Inclusion Criteria
- •be older than 18 years of age
- •have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings
- •both study teeth must be vital (tested with cold)
- •both study fillings must be visible on the cheek-side of the tooth.
Exclusion Criteria
- •do not meet all inclusion criteria
- •are under active orthodontic treatment
- •have severe medical complications
- •have dry mouth
- •have chronic gum disease or poor oral hygiene
- •are unavailable for long term recall (minimum of 2 years required)
- •cannot tolerate the rubber dam
- •have an unstable tooth contacts
- •have severe bruxing or clenching, or are in need of jaw joint therapy
- •are pregnant or breastfeeding.
Outcomes
Primary Outcomes
Number of participants with restoration failure of either material
Time Frame: 2 years
Restoration failure is based on clinical performance criteria according to the Fédération Dentaire Internationale (FDI) rating system. An assessment of score 5, indicating poor performance, in any of the three categories esthetic, functional or biological performance will be considered a failure.
Secondary Outcomes
- Clinical performance score for each restoration(2 years)
- Confirmation of material safety(2 years)