根据移植物的位置,使用改良的冠状先进隧道和上皮下结缔组织移植物治疗多发性牙龈退缩的评估
研究概览
地位
条件
详细说明
病情或疾病:多发性牙龈退缩
干预/治疗:
装置:改良的冠状先进隧道,带有结缔组织移植物,内侧朝向皮瓣 装置:改良的冠状先进隧道,带有上皮下结缔组织移植物,外侧朝向皮瓣 阶段:不适用
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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MAzowsze
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Warsaw、MAzowsze、波兰、00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
纳入标准:
- 年龄≥18岁
- 同一牙弓的同源牙齿双侧多处牙龈退缩。
排除标准:
- 全口牙菌斑指数 ≥ 20% (Ainamo & Bay 1975)
- 全口龈沟出血指数 ≥ 15% (Mühlemann & Son 1971)
- 抽烟
- 感染性疾病治愈潜力受损的全身性疾病
- 影响牙周健康/愈合的药物
- 怀孕及哺乳期女性
- 该区域既往接受过牙周手术
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:The tunnel technique for root coverage with CTG with outer side of the graft
Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study |
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG).
A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions.
The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap.
The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
|
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实验性的:The tunnel technique for root coverage with CTG with inner side of the graft
Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study. |
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG).
A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions.
The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation).
The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Change in Gingival Recession (Mean Root Coverage, MRC)
大体时间:Baseline and 6 months after surgery
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Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%.
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Baseline and 6 months after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
大体时间:6 months after surgery
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The analyzed metrics were calculated as follows: GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome
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6 months after surgery
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Root Coverage Esthetic Score (RES)
大体时间:6 months after surgery
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RES:The following variables were assessed:
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6 months after surgery
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合作者和调查者
调查人员
- 首席研究员:Bartłomiej Górski, PhD、Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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