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

N/ANot Yet RecruitingNCT06875544

Future University in Egypt50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

DME Dental Deep Margin Elevation

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recurrent caries

* 0: no evidence of caries continuous along the margin * 1: caries evident continuous with the margin of restoration

Time frame: T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

Secondary Outcomes

1. Post-operative sensitivity. 2. Fracture of Restoration. 3. Bleeding on probing

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