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.

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07432724

Enrollment

Registered

2026-02-25

Start date

2026-08-01

Completion date

2028-04-01

Last updated

2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus (DM)

Keywords

Bioactive composite

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.

Interventions

OTHERbioactive composite

the bioactive component present in the composite restoration.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Contacts

CONTACTSara Mohamed Manaa, PhD

sara.mohamed.manaa@hotmail.com00201022484815

CONTACTyomna sayed, lecturer

yomna.sayed@dentistry.cu.edu.eg00201006781076

STUDY_DIRECTORRania Mosallam, Professor

Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026