Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Root coverage after 6 months
研究概览
简要总结
Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.
The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The clinical parameters were screened by one single examiner that was not aware of the procedures
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CEJ without significant damage;
- •localized bilateral RT1 gingival recession ≥3 mm in the same arch
排除标准
- •previous periodontal surgical treatment on the involved sites;
- •pregnants or lactating
- •compromised systemic health and contraindications for periodontal surgery
研究组 & 干预措施
Test Group
Active comparator: gingival recession
the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions
干预措施: Root coverage with collagen matrix graft (Procedure)
Test Group
Active comparator: gingival recession
the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions
干预措施: Basic periodontal treatment (Other)
Control Group
the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.
干预措施: Root coverage with subepithelial connective tissue graft (Procedure)
Control Group
the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.
干预措施: Basic periodontal treatment (Other)
结局指标
主要结局
Root coverage after 6 months
时间窗: 6 months
Root coverage is measured by the difference between the gingival recession height at 6 months and baseline
次要结局
- Keratinized tissue gain after 6 months(6months)
研究者
Arthur Belem Novaes Jr
Phd, Ms, DDs. Chairman of Periodontolgy
University of Sao Paulo