Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites

Study Overview
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Brief Summary
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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.

Official Title
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Two-year Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites in Class ӀӀ Restorations: A Randomized Clinical Trial

Conditions
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Dental Caries Class II

Intervention / Treatment
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* Procedure: Fill-Up Class ӀӀ restoration
* Procedure: QuiXfil Class ӀӀ restoration
* Procedure: Tetric N-Ceram Bulk Fill Class ӀӀ restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient received three Class ӀӀ restorations with the three tested bulk-fill resin composites.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fill-Up<br>Bulk-fill resin composite type | Procedure: Fill-Up Class ӀӀ restoration<br>* Bulk-fill technique<br>|
| Active Comparator: QuiXfil<br>Bulk-fill resin composite type | Procedure: QuiXfil Class ӀӀ restoration<br>* Bulk-fill technique<br>|
| Active Comparator: Tetric N-Ceram Bulk Fill<br>Bulk-fill resin composite type | Procedure: Tetric N-Ceram Bulk Fill Class ӀӀ restoration<br>* Bulk-fill technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetic properties (FDI criteria) | 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). | From baseline to 2-year follow-up | 
| Functional properties (FDI criteria) | 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). | From baseline to 2-year follow-up | 
| Biological properties (FDI criteria) | 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). | From baseline to 2-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulk-fill resin composite, Dual-cure, Light-cure, Class ӀӀ restorations, Clinical performance, Randomized clinical trial