Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Recession depth (REC): (Change in the amount of root coverage)
研究概览
简要总结
this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).
详细描述
The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis & Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good general health.
- •No contraindications for periodontal surgery.
- •Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).
- •The cemento-enamel junction (CEJ) is visible in the defective teeth.
- •All patients demonstrating good plaque control.
- •No previous periodontal surgery in the targeted area.
排除标准
- •pregnant or nursing patients.
- •history of malignancy, radiotherapy, or chemotherapy.
- •Patients taking medications that affect mucosal healing.
- •Patients with allergy to collagen.
- •Previous participation in a clinical trial.
- •Type-1 diabetes patients.
- •Patient who have diseases that affect connective tissue metabolism.
研究组 & 干预措施
(XCM)+(CAF)
Surgical protocol for test treatment with CAF + XCM:
After local anesthetizing the recipient site,CAF elevation will be done using (De Sanctis & Zucchelli 2007) design.Horizontal incisions will be done at the recession site,another two slightly divergent vertical incisions will be done at the end of previous incisions extending to the mucogingival junction.The resulting flap will be split thickness in the surgical papillae area,then will be full thickness exposing 3-4 mm of the bone apically of the dehiscence and after that it will be split thickness in the apical direction,all the muscle insertions will be eliminated,the root surface will be prepared by curettes and chemically treated with 24% EDTA gel.De-epithelialization of the interdental papillae will be done.The XCM will be trimmed and fix onto the root surface 1-2mm coronally of the CEJ using absorbable sutures,and the flap will be coronally advanced to fully cover the XCM and then sutured to the de-epithelialized papillae.
干预措施: (XCM)+(CAF) (Procedure)
(SCTG)+(CAF)
The surgical protocol in the control group will be identical with test group protocol with these exceptions:
- The entire flap will be elevated as split thickness instead of split-full-split thickness flap.
- A SCTG harvested from the palate will be used to cover the exposed denuded root surface in lieu of placement of XCM in the test group. And absorbable sutures will be used to stabilize it 2 mm coronally from the CEJ.
- As in the test group the mucosal flap will coronally advanced to completely cover the SCTG then sutured to the de-epithelialized papillae.
干预措施: (SCTG)+(CAF) (Procedure)
结局指标
主要结局
Recession depth (REC): (Change in the amount of root coverage)
时间窗: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).
次要结局
- change in visible plaque index:(1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative)
- Pain index (PI)(1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.)
- Clinical attachment level (CAL)(1) at baseline, 2) at 3 months postoperative.)
- Recession width (RW)(1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.)
- Width of keratinized tissue (KT)(1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.)
- Probing depth (PD)(1) at baseline, 2) and 3 months postoperative.)
- Healing index(1) at two weeks following surgery and (2) at one month following surgery.)
- Thickness of gingival tissue (GT)(1) at baseline, and 2) 3 months postoperative.)
- Patient Perceptions(at three months post-surgery.)
- Change in root sensitivity(1) at baseline, 2) and at 3 months postoperative.)