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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of patient satisfaction in terms of post-operative pain. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hala A. Abu El-Ela, Professor | Faculty of Dentistry- Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry- Ain Shams University | Cairo | Egypt |
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| Label | URL |
|---|---|
| Pubmed in a database that has been used globally for research purposes | View source |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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. |
| assessment at two weeks postoperative time. |
| Evaluation of patient satisfaction in terms of final esthetic appearance. | 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. | The change from enrollment to 24 weeks |
| D055093 |
| Periodontal Atrophy |