Augmentation of Keratinized Tissue Around Dental Implant With Combined Application of a Xenogeneic Collagen Matrix and the Free Gingival Graft : a Single Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- change from baseline keratinized mucosa width at 2 and 6 months
研究概览
简要总结
The purpose of this study is to compare the clinical effects of combined application of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft.
详细描述
The purpose of this study is to compare the clinical effects of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft. This study designed a single arm clinical trial. The included patients will all be treated with apical repositioned flap with a xenogeneic collagen matrix and the free gingival graft. The width of keratinized mucosa, thickness of keratinized mucosa, gingival index, probing depth will be measured before surgery and at 2, 6 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >=18 years and periodontally and systemically healthy;
- •Presence of at least one site with <=2 mm of keratinized tissue; associated with a shallow vestibule in the edentulous region after implant surgery (no more than three consecutive implants);
- •Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
- •Full mouth probing depths <=5mm;
- •Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <=15%;
- •Be able to comply with all procedures related to the study.
排除标准
- •Pregnant or lactating women;
- •Untreated periodontal disease;
- •Presence of systemic disorders (diabetes, heart disease, tumor or any other condition that could contraindicate periodontal surgery);
- •Use of medications (immunosuppressants, phenytoin, or anything else that might affect mucosal healing and repair);
- •Under radiotherapy;
- •Allergy to the collagen;
- •Previous mucogingival surgery in the area.
结局指标
主要结局
change from baseline keratinized mucosa width at 2 and 6 months
时间窗: baseline, at 2,6 months
measured from the mucogingival junction to the mucosa margin or the zenith of alveolar ridge at the mid-buccal aspect of each implant using a periodontal probe (UNC15)
次要结局
- change from baseline keratinized mucosa thickness at 2 and 6 months(baseline, at 2,6 months)
- Post-operative pain(at 1 week after surgery)
- change from baseline Gingival index at 2 and 6 months(baseline, at 2,6 months)
- change from baseline probing depth at 2 and 6 months(baseline, at 2,6 months)
- change from 2 months patient satisfaction at 6 months(at 2 and 6 months post operation)
- dosage of postoperative analgesic drugs(at 1 week after surgery)
- operation time(during the surgery)
- esthetic score(at 6 months post operation)
- change from baseline depth of recession at 2 and 6 months(baseline, at 2,6 months)
- change from baseline width of recession at 2 and 6 months(baseline, at 2,6 months)
研究者
Peihui Ding
Principal Investigator
The Dental Hospital of Zhejiang University School of Medicine