Comparison of Graft Quality and Patient Morbidity Following Four Different Connective Tissue Graft Harvesting Techniques. A Randomized Controlled Feasibility Study

University of Milan2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2018年8月16日最近更新: 2020年6月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Milan
入组人数: 60
试验地点: 2
主要终点: Patient morbidity (VAS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity

详细描述

The primary aim is to compare 4 different connective tissue graft harvesting techniques in terms of morbidity and in terms of quality of the graft.

The secondary aim is to evaluate the outcome of gingival recessions treated with grafts obtained from different harvesting approaches, in terms of mean root coverage, complete root coverage, keratinized tissue gain, clinical attachment level gain and gingival thickness

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 (Participant, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 years of age or greater,
•Patients with no reported systemic diseases,
•Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy,
•Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15%,
•Clinical indication for periodontal plastic surgery utilizing CTG to treat either a single or a maximum of two recession defects (Miller class I, II) around natural teeth
•No history of previous palatal harvesting

排除标准

•Pregnancy
•Systemic condition that generally precludes surgical therapy or that could influence the outcome of therapy (e.g. Diabetes with HbA1c > 7%, INR > 3 etc.)
•Non-compensated systemic disease
•Poor oral hygiene with full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) > 20% at baseline
•Inadequate endodontic treatment or tooth mobility at the site of surgery
•Radiographic evidence of bone loss

研究组 & 干预措施

De-epithelialized gingival graft (DGG)

Experimental

A harvesting approach where the a graft is obtained from the superficial palate and then extra-orally de-epithelialized in order to obtain a connective tissue graft (DGG harvesting approach) Then the DGG is used for treating gingival recessions (root coverage procedure)

干预措施: DGG Harvesting approach (Procedure)

De-epithelialized gingival graft (DGG)

Experimental

干预措施: Root coverage procedure (Procedure)

Envelope technique (ET)

Experimental

A harvesting approach where only one horizontal incision is performed on the palate (ET harvesting approach) for harvesting a connective tissue graft.