Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation

Not Applicable

Not yet recruiting

• Conditions: DME; Dental; Deep Margin Elevation

• Registration Number: NCT06875544
• Lead Sponsor: Future University in Egypt

Brief Summary

Using a bioactive resin composite in subgingival Class II cavities can provide enhanced caries resistance by releasing multiple ions, including fluoride. This approach offers greater resistance to caries due to the incorporation of surface pre-reacted glass filler (S-PRG) technology (Imazato, Nakatsuka et al., 2023).

This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-08
• Last Update Submitted: 2025-03-08
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

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

Inclusion Criteria

1. Adult Patient (20-50 years old)
2. Good oral hygiene (plaque index 0 or 1)
3. Patient approval
4. Absence of parafunctional habits and/or bruxism
5. No endodontic treatment
6. No abscess
7. No partial or fixed denture

Exclusion Criteria

1. Patients with known allergic or adverse reaction to the tested materials.
2. Bad oral hygiene
3. Systematic disease that may affect participation.
4. Xerostomic patients.
5. Patients with active periodontal disease.
6. Heavy smokers (those who smoke greater than or equal to 25 or more cigarettes a day)
7. Orthodontic treatment patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recurrent caries	T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months	* 0: no evidence of caries continuous along the margin; * 1: caries evident continuous with the margin of restoration

Secondary Outcome Measures

Name	Time	Method
1. Post-operative sensitivity. 2. Fracture of Restoration. 3. Bleeding on probing	T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months	1. Post-operative sensitivity.; * 1: Absent; * 2: Present; 2. Fracture of Restoration.; * 1: Restoration is intact and fully retained.; * 2: Restoration is partially retained with some portion of the restoration still intact.; * 3: Restoration is completely missing; 3. Bleeding on probing; * 0: Healthy gums; * 1: Bleeding on probing 2:periodontal problem with bone loss