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NCT Number: NCT07162207

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry- Ain Shams University

Cairo, Egypt

About this study

Twenty patients with localized gingival recession were randomly assigned into two equal groups. The control group received treatment with modified 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. The change in depth of gingival recession (RD)

    Time frame: The change from enrollment to 24 weeks.

    -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.
  2. The change in the width of gingival recession.

    Time frame: The change from enrollment to 24 weeks.

    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.
  3. Plaque index (PI):

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

    • 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.
  4. Gingival index (GI)

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

    • 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.
  5. Probing depth (PD)

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

    • 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.
  6. Clinical attachment level (CAL)

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

    • Clinical attachment level is measured from the cemento-enamel junction (CEJ) to the depth of the gingival sulcus.
  7. Percentage of mean root coverage (MRC %)

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

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

  8. Width of keratinized tissue (KTW)

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

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

  9. Gingival thickness (GT)

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

    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.

Secondary outcomes

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

    Time frame: assessment at two weeks postoperative time.

    It's assessed by using verbal, numeric scale and by recording amount of analgesic intake postoperatively. The numerical rating Scale (NRS) pain score: is a psychometric response to pain reported by the patient directly through a score (between 0 and 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain). This was done through a questionnaire two weeks after surgery.

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

    Time frame: The change from enrollment to 24 weeks

    The clinical parameter: Root coverage esthetic score (RES) will be measured to evaluate the secondary outcome, time of evaluation at 6 months follow up time.

    • It is used to evaluate five variables and recorded at 6 months following surgery; these variables are gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MCJ alignment and gingival color (GC). Then; giving score for each variable and added them to give score as the following GM: zero points= failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points= partial root coverage; 5 points= Complete root coverage (CRC). MTC, STT, MGJ, GC are given zero point and 1 point according to certain criteria.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Modified Pinhole Surgical Technique Using Bi-layer Collagen Membrane Versus Subepithelial Connective Tissue Graft in the Treatment of Localized Gingival Recession: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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