Prospective, Randomized, Controlled, Double Blind Trial of Two Universal Composites in Posterior Teeth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Caries
- Sponsor
- Hacettepe University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.
Detailed Description
A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria. Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (p\<0.05).
Investigators
Zeynep Bilge Kutuk
Research Assistant
Hacettepe University
Eligibility Criteria
Inclusion Criteria
- •a need for at least two but not more than four posterior tooth-colored restorations
- •the presence of teeth to be restored in occlusion
- •teeth that were symptomless and vital
- •a normal periodontal status
- •a good likelihood of recall availability.
Exclusion Criteria
- •partly erupted teeth
- •absence of adjacent and antagonist teeth
- •poor periodontal status
- •adverse medical history
- •potential behavioral problems.
Outcomes
Primary Outcomes
Observers evaluated the esthetic properties of the restorations using FDI (World Dental Federation) Criteria.
Time Frame: The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.
"Surface luster"; "Staining (surface, margins)"; "Color match and translucency"; "Esthetic anatomical form"
Secondary Outcomes
- Observers evaluated the functional properties of the restorations using FDI (World Dental Federation) Criteria.(The changes at restorations were obtained from baseline (one week after treatment), 6 month, 1, 2, 3 and 4 year.)