Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites
Two-year Clinical Performance of Dual- and Light-cure Bulk-fill Resin Composites in Class ӀӀ Restorations: A Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aldakhlia
-
Mansoura, Aldakhlia, Egypt, 35516
- Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fill-Up
Bulk-fill resin composite type
|
Bulk-fill technique
|
|
Active Comparator: QuiXfil
Bulk-fill resin composite type
|
Bulk-fill technique
|
|
Active Comparator: Tetric N-Ceram Bulk Fill
Bulk-fill resin composite type
|
Bulk-fill technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Esthetic properties (FDI criteria)
Time Frame: 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). |
From baseline to 2-year follow-up
|
|
Functional properties (FDI criteria)
Time Frame: 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). |
From baseline to 2-year follow-up
|
|
Biological properties (FDI criteria)
Time Frame: 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). |
From baseline to 2-year follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A01150620
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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