Bi-layer Collagen Membrane Versus Subepithelial Connective Tissue Graft in the Treatment of Localized Gingival Recession

Ain Shams University

Status: Active, not recruiting

Conditions: Gingival Recession, Localized

Treatments: Procedure: Pinhole surgical technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07162207

FDASU-REC 052317

Details and patient eligibility

About

The goal of this clinical trial is evaluation of the change in depth and width of gingival recession in terms of gingival thickness and esthetics, and evaluation of patient satisfaction in terms of postoperative pain and final esthetic appearance.

The study will be conducted on twelve Egyptian healthy patients with localized gingival recession. Researchers will compare clinical effectiveness of collagen membrane to connective tissue graft in treatment of localized gingival recession. The study hypothesis is that no difference exists between Bilayer collagen membrane combined with Pinhole approach and CT graft combined with Pinhole approach used for root coverage in treatment of localized gingival recession.

Full description

Twelve patients with localized gingival recession were randomly assigned into two equal groups. The control group received treatment with Pinhole surgical approach using connective tissue graft material, while the comparison group received treatment with Pinhole surgical approach using collagen membrane. Patients were followed up after 3 and 6 months from treatment.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients have ages above 18 years.
2. Patients included in the study are classified with Cairo RT1 and RT2 localized recession defect Cairo et al. (2011).
3. Patients have at least 1 mm of residual keratinized tissue.
4. Recession depth ≥ 2mm.
5. Recession is not caused by periodontal disease.
6. Patients have good oral hygiene.

Exclusion criteria

1. Patients with systemic diseases.
2. Pregnant and lactating women.
3. Smoking patients and drug abusers.
4. Patients with mal-positioned and rotated teeth.
5. Patients with periodontally affected teeth adjacent to the treated sites.
6. Patients having carious lesions or restorations in the treated teeth.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Sub Epithelial Connective tissue graft

Active Comparator group

Description:

A pinhole is created in the site of recession. After harvesting the connective tissue graft from the palate it's trimmed and inserted in the tunnel.

Treatment:

Procedure: Pinhole surgical technique

Bi-layer collagen membrane

Experimental group

Description:

A pinhole is created in the site of recession, the Bi-layer collagen membrane is trimmed to fit the size of the recession defect, followed by membrane insertion in the tunnel.

Treatment:

Procedure: Pinhole surgical technique