Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites
- Conditions
- Dental Caries Class II
- Interventions
- Procedure: QuiXfil Class ӀӀ restorationProcedure: Fill-Up Class ӀӀ restorationProcedure: Tetric N-Ceram Bulk Fill Class ӀӀ restoration
- Registration Number
- NCT06137989
- Lead Sponsor
- Mansoura University
- Brief Summary
This study (a double-blinded, prospective, randomized clinical trial) aimed to evaluate 2-year clinical performance of dual- and light-cure bulk-fill resin composites in Class ӀӀ restorations.
The null hypothesis tested in this study was that, there would be no difference in the 2-year clinical performance of all tested bulk-fill resin composites in Class II restorations.
Forty patients were enrolled in the study. Each patient received three bulk-fill resin composites Class ӀӀ restorations. One dual-cure and two light-cure bulk-fill resin composites were used for Class ӀӀ restorations following manufacturer's instructions. A universal adhesive was used with all restorations. All restorations were clinically evaluated after 1 week (baseline), 6 months, 12 months, 18 months and finally after 24 months using the FDI World Dental Federation criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- each participant should have at least three permanent molars and premolars that need to be treated with Class II restorations due to primary carious lesions.
- all participants required to have a full and normal occlusion and to maintain adequate oral hygiene.
General exclusion criteria:
- heavy bruxism.
- poor oral hygiene.
- chronic or severe periodontitis.
- a history of allergies to any of the materials utilized in this study.
- pregnant or nursing females.
Specific exclusion criteria:
- fractured or visibly cracked teeth.
- rampant caries.
- faulty restoration opposite or adjacent to the tooth to be restored.
- atypical extrinsic staining.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QuiXfil QuiXfil Class ӀӀ restoration Bulk-fill resin composite type Fill-Up Fill-Up Class ӀӀ restoration Bulk-fill resin composite type Tetric N-Ceram Bulk Fill Tetric N-Ceram Bulk Fill Class ӀӀ restoration Bulk-fill resin composite type
- Primary Outcome Measures
Name Time Method Esthetic properties (FDI criteria) From baseline to 2-year follow-up Including five parameters (surface luster, margin staining, surface staining, color match \& translucency, and esthetic anatomical form).
Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome.
Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).Functional properties (FDI criteria) From baseline to 2-year follow-up Including five parameters (marginal adaptation, occlusal wear, proximal contact, radiographic examination, and fracture of material \& retention).
Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome.
Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).Biological properties (FDI criteria) From baseline to 2-year follow-up Including three parameters (post-operative sensitivity, recurrence of caries, and tooth integrity).
Each parameter is exhibited by five scores (1, 2, 3, 4, 5), score 1 is the best outcome.
Three scores for acceptable (1, 2, 3) and two scores for non-acceptable (4 for reparable and 5 for replacement).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
🇪🇬Mansoura, Aldakhlia, Egypt