i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Efficacy of a Novel i-PRF-based Bioactive Matrix in the Treatment of Gingival Recessions: a Randomized Controlled Clinical Trial
This study aims to evaluate the efficacy of a novel bioactive matrix, consisting of an equine collagen core soaked in i-PRF and wrapped in L-PRF, used in combination with a coronally advanced flap as an alternative to the autologous connective tissue graft for the treatment of gingival recessions. In this randomized controlled clinical trial, 24 patients with Miller Class I or II recessions will be treated with either the bioactive matrix (test) or a subepithelial connective tissue graft (control), with calibrated and blinded examiners. The primary endpoints are mean and complete root coverage at 6 months, while secondary outcomes include clinical parameters and patient-reported outcome measures (PROMs) on post-operative discomfort and satisfaction, recorded at baseline, 3 and 6 months.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Chieti
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Chieti、Chieti、意大利、66100
- 招聘中
- Department of Innovative Technologies in Medicine and Dentistry, University 'G. D'Annunzio' of Chieti
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接触：
- Michele Paolantonio, DDS, MS
- 电话号码：08713554158
- 邮箱：michelepaolantonio@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria Age ≥ 18 years Systemically healthy non-smokers Willingness to provide informed consent and attend the study No antibiotic use within the previous 3 months No known allergies to the materials used in the study No periodontal plastic surgery at the defect site within the previous 12 months Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 20% Miller Class I or II (RT1) buccal gingival recessions at maxillary or mandibular incisors, canines or premolars, single or multiple Recession depth ≥ 2 mm Exclusion criteria Unstable systemic diseases Compromised healing potential (e.g. diabetes) Active infectious diseases (hepatitis, tuberculosis, HIV, etc.) Use of steroid medications Pregnancy or attempting to become pregnant Use of medications known to cause gingival enlargement
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CAF+iPRF based Bioactive Matrix
Coronally advanced flap (CAF) with a bioactive matrix (equine collagen soaked in i-PRF and wrapped in a double L-PRF membrane) |
An equine collagen matrix is trimmed to the size of the site, soaked in autologous i-PRF and wrapped in a double layer of L-PRF membranes. The resulting bioactive matrix is secured to the de-epithelialized papillae with simple interrupted sutures and fully covered by the flap. |
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有源比较器：CAF+SCTG
CAF with a de-epithelialized subepithelial connective tissue graft harvested from the palate |
A free epithelialized gingival graft is harvested from the palate, de-epithelialized with a 15c blade and sutured at the level of the CEJ. The graft height is based on the distance from the CEJ to the buccal bone crest. The flap is then advanced to fully cover it. |
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 |
|---|---|---|
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Gingival thickness (GT)
大体时间：3 months and 6 months
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Measured mid-buccally, 2 mm apical to the gingival margin, using a endodontic file with a rubber stopper |
3 months and 6 months
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Mean root coverage (mRC)
大体时间：3 months and 6 months
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percentage of baseline recession depth (RECd) covered |
3 months and 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.