NCT07432724
Not yet recruiting
Not Applicable
A Prospective Clinical Evaluation of Bioactive Restorative System in Controlled Diabetic and Non Diabetic Patients: An 18-Month Non-Randomized Comparative Study.
Interventionsbioactive composite
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 50
- Primary Endpoint
- Marginal discoloration
Overview
Brief Summary
This study is conducted to evaluate the 18-month clinical performance of complete bioactive restorative system for occlusal restorations between diabetic and non-diabetic patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients indicated for a Class I posterior composite restoration
- •permanent tooth
- •ICDAS 3 or 4
Exclusion Criteria
- •uncontrolled diabetic patients
- •primary dentition
- •special needs
Arms & Interventions
diabetic patients
Experimental
Intervention: bioactive composite (Other)
Non diabetic patients
Experimental
Intervention: bioactive composite (Other)
Outcomes
Primary Outcomes
Marginal discoloration
Time Frame: T0: Baseline T1: 6 months T2: 12 months T3: 18 month
Measuring device: Modified USPHS criteria
Secondary Outcomes
- Marginal adaptation, color match, secondary caries, Retention, wear, and postoperative sensitivity.(T0: baseline T1: 6 months T2: 12 months T3: 18 months)
Investigators
Sara Mohamed Hassan
Assistant lecturer
Cairo University
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