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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bioactive composite.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus (DM). Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Clinical Evaluation of Bioactive Restorative System in Controlled Diabetic and Non Diabetic Patients: An 18-Month Non-Randomized Comparative Study.
Overview
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
- Other bioactive composite
the bioactive component present in the composite restoration.
Primary outcome measures
- Marginal discoloration [Time frame: T0: Baseline T1: 6 months T2: 12 months T3: 18 month]
Secondary outcome measures (1)
- Marginal adaptation, color match, secondary caries, Retention, wear, and postoperative sensitivity. [Time frame: T0: baseline T1: 6 months T2: 12 months T3: 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07432724 · 09061992