18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations

Not Applicable

Not yet recruiting

• Conditions: Occlusal Caries

• Registration Number: NCT06956651
• Lead Sponsor: Cairo University

Brief Summary

The study compares two restorative materials to restore occlusal decay, offering the patients high-strength, high-durability restorations with antibacterial properties.

Detailed Description

There is no available evidence discussing the FIT SA restorative material in the restoration of occlusal lesions. This study aims to provide valuable insights into the clinical performance of this restorative material compared to the gold standard.

Study Timeline

• Study First Submitted: 2025-04-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-01
• Study First Posted: 2025-05-04
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Start: 2025-09
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Posterior vital tooth with Class I caries.

Exclusion Criteria

• Teeth with clinical symptoms of pulpitis, such as spontaneous pain.
• Pain or sensitivity to pressure.
• Non-vital teeth.
• Fractured or cracked teeth.
• Endodontically treated teeth.
• Periodontally affected teeth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical performance	18 months	Clinical performance using the Modified United States Public Health Service criteria, values: alpha (upper value - better outcome), charlie (lower value- worse outcome).