Gingival Recession, Localized
Conditions
Keywords
Gingival recession, pinhole surgical technique, Connective tissue graft, Bi-layer collagen membrane
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.
Detailed description
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.
Interventions
PROCEDUREPinhole 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of patient satisfaction in terms of post-operative pain. | 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. |
| Evaluation of patient satisfaction in terms of final esthetic appearance. | 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. |
Countries
Egypt
Contacts
STUDY_DIRECTORHala A. Abu El-Ela, Professor
Faculty of Dentistry- Ain Shams University
Outcome results
None listed