Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations

Not Applicable

Not yet recruiting

• Conditions: Deep Caries; Caries, Dental

• Registration Number: NCT06882343
• Lead Sponsor: Future University in Egypt

Brief Summary

The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-18
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adults patients (20-50)
• Good oral hygiene (plaque index 0 or 1 )
• Patient approving to participate in the study
• Absence of parafunctional habits and/or bruxism

Exclusion Criteria

• Patients with known allergic or adverse reaction to the tested materials.
• Systematic disease that may affect participation.
• Xerostomic patients.
• Bad oral hygiene (plaque index 2 or 3 )
• Heavy smokers
• Patients undergoing or will start orthodontic treatment
• Patients with removable prothesis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrent caries	1 week, 6 months and 12 months	* Yes: no evidence of caries continuous along the margin; * No: caries evident continuous with the margin of restoration

Secondary Outcome Measures

Name	Time	Method
Post-operative sensitivity	1 week, 6 months and 12 months	* No: Absent; * Yes: Present
Fracture of the restoration	1 week, 6 months and 12 months	* Restoration is intact and fully retained.; * Restoration is partially retained with some portion of the restoration still intact.; * Restoration is completely missing
Bleeding on probing	1 week, 6 months and 12 months	* 0 Healthy gums; * 1 Bleeding on probing; * 2 periodontal problem with bone loss