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Clinical Trials/NCT07432724
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.

Cairo University0 sites50 target enrollmentStarted: August 1, 2026Last updated:
Interventionsbioactive composite

Overview

Phase
Not Applicable
Status
Not yet recruiting
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sara Mohamed Hassan

Assistant lecturer

Cairo University

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