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.

February 24, 2026 updated by: Sara Mohamed Hassan, Cairo University

A Prospective Clinical Evaluation of Bioactive Restorative System in Controlled Diabetic and Non Diabetic Patients: An 18-Month Non-Randomized Comparative Study.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diabetic patients
Other: bioactive composite
the bioactive component present in the composite restoration.
Experimental: Non diabetic patients
Other: bioactive composite
the bioactive component present in the composite restoration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal discoloration
Time Frame: T0: Baseline T1: 6 months T2: 12 months T3: 18 month
Measuring device: Modified USPHS criteria
T0: Baseline T1: 6 months T2: 12 months T3: 18 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal adaptation, color match, secondary caries, Retention, wear, and postoperative sensitivity.
Time Frame: T0: baseline T1: 6 months T2: 12 months T3: 18 months
measuring device: Modified USPHS criteria
T0: baseline T1: 6 months T2: 12 months T3: 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Rania Mosallam, Professor, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09061992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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