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.

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.

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Key information

Conditions

Diabetes Mellitus (DM) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bioactive composite

Other

the bioactive component present in the composite restoration.

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.

Time frame: T0: baseline T1: 6 months T2: 12 months T3: 18 months

measuring device: Modified USPHS criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Mohamed Manaa, PhD

CONTACT

[email protected]

00201022484815 ext. 002

yomna sayed, lecturer

CONTACT

[email protected]

00201006781076 ext. 002

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Feb 25, 2026
Registry last updated: Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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