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

Condition(s) studied

Investigational drug(s) / intervention(s)

Pinhole surgical technique: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• The change in depth of gingival recession (RD) — 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.
• The change in the width of gingival recession. — 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.
• Plaque index (PI): — 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.
• Gingival index (GI) — 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.
• Probing depth (PD) — 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.
• Clinical attachment level (CAL) — 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.
• Percentage of mean root coverage (MRC %) — 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 % ).
• Width of keratinized tissue (KTW) — 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.
• Gingival thickness (GT) — 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.

Trial sites (1)

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