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

NCT07162207 | Active Not Recruiting DMC

• 1 other identifier: FDASU-REC 052317
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession, Localized

Keywords

Gingival recession; pinhole surgical technique; Connective tissue graft; Bi-layer collagen membrane

Outcome Measures

Primary Outcomes (9)

• The change in depth of gingival recession (RD)

  -This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters). \- This parameter will be recorded at baseline (just prior to the surgery) as well as at the 3rd month and 6th month follow up for Group 1 and Group 2.

  The change from enrollment to 24 weeks.

• The change in the width of gingival recession.

  This clinical parameter will be measured to evaluate the primary outcome: (unit of measurement: millimeters). \- This parameter will be recorded at baseline (just prior to the surgery) as well s at the 3rd month and 6th month follow up for Group 1 and Group 2.

  The change from enrollment to 24 weeks.

• Plaque index (PI):

  \- Plaque index is based on recording both soft debris and mineralized deposits for each surface of the teeth (buccal, lingual, mesial and distal). Each of the four surfaces of the teeth is given a score from 0-3.

  This parameter is measured at baseline, 3 and 6 months postoperatively.

• Gingival index (GI)

  \- Gingival index is measured by giving a score from 0-3 for each surface of the four surfaces of the tooth then divided by four to give gingival index of each tooth.

  This parameter is measured at baseline, 3 and 6 months postoperatively.

• Probing depth (PD)

  \- Probing depth is measured from the gingival margin to the depth of the gingival sulcus using UNC-15 periodontal probe at 6 sites for each tooth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual surface.

  This parameter will be recorded at baseline, 3 and 6 months postoperatively.

• Clinical attachment level (CAL)

  \- Clinical attachment level is measured from the cemento-enamel junction (CEJ) to the depth of the gingival sulcus.

  CAL will be measured at baseline, 3 and 6 months postoperatively.

• Percentage of mean root coverage (MRC %)

  Percentage of mean root coverage is calculated as: (\[RD preoperative - RD postoperative\]/ RD preoperative) × 100 % (unit of measurement: Percentage % ).

  MRC% is recorded at baseline, 3 and 6 months postoperatively.

• Width of keratinized tissue (KTW)

  Width of keratinized tissue (KTW) is measured from the most apical extension of gingival margin to the mucogingival line.

  This parameter is measured at baseline, 3 and 6 months postoperatively.

• Gingival thickness (GT)

  Gingival thickness (GT) is measured using UNC-15 periodontal probe with piercing the mucosal surface at a right angle with slight pressure until reaching the hard tissue. The distance between the tip of the probe and the outer mark is measured.

  This parameter is recorded at baseline, 3 and 6 months postoperative.

Secondary Outcomes (2)

• Evaluation of patient satisfaction in terms of post-operative pain.

  assessment at two weeks postoperative time.

• Evaluation of patient satisfaction in terms of final esthetic appearance.

  The change from enrollment to 24 weeks

Study Arms (2)

Sub Epithelial Connective tissue graft

ACTIVE COMPARATOR

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.

Procedure: Pinhole surgical technique

Bi-layer collagen membrane

EXPERIMENTAL

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.

Procedure: Pinhole surgical technique

Interventions

Pinhole surgical technique PROCEDURE

A pinhole is created in the site of recession, the grafting material (Bi-layer collagen membrane versus connective tissue graft) is trimmed to fit the size of the recession defect, followed by graft insertion in the tunnel.

Bi-layer collagen membrane; Sub Epithelial Connective tissue graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry- Ain Shams University

Cairo, Egypt

Location

Related Links

• Pubmed in a database that has been used globally for research purposes

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Hala A. Abu El-Ela, Professor

  Faculty of Dentistry- Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Oral Medicine and Periodontology

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 9, 2025
• Study Start: June 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)