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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The change in depth of gingival recession (RD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sub Epithelial Connective tissue graft
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.
干预措施: Pinhole surgical technique (Procedure)
Bi-layer collagen membrane
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.
干预措施: Pinhole surgical technique (Procedure)
结局指标
主要结局
The change in depth of gingival recession (RD)
时间窗: 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.
时间窗: 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):
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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 %)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Evaluation of patient satisfaction in terms of final esthetic appearance.(The change from enrollment to 24 weeks)
- Evaluation of patient satisfaction in terms of post-operative pain.(assessment at two weeks postoperative time.)
研究者
Aya Elleithy
Assistant lecturer of Oral Medicine and Periodontology
Ain Shams University