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临床试验/NCT07100808
NCT07100808已完成不适用

Evaluation of Clinical Efficacy of Subepithelial Connective Tissue Graft and Free Gingival Graft De-Epithelialized With Two Different Methods in the Treatment of Gingival Recessions

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
The percentage of Root Coverage (RCP)

研究概览

简要总结

The aim of this study is to evaluate the clinical effectiveness of three techniques used in combination with the tunnel method for the treatment of multiple gingival recessions: subepithelial connective tissue graft (SCTG Group), scalpel-de-epithelialized free gingival graft (Scalpel Group), and Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet (Er,Cr:YSGG) laser-de-epithelialized free gingival graft (Laser Group).

详细描述

Gingival recession is not only one of the most common aesthetic and functional problems of the periodontium, but also one of the most complex conditions in terms of etiology and treatment modalities. Subepithelial connective tissue grafts (SCTG), applied in combination with various techniques, are considered the gold standard in the treatment of gingival recession. In cases where a surgical approach is indicated, coronally advanced flap (CAF) or graft-based subepithelial connective tissue procedures in combination with the tunnel technique (TT) have been reported to be successfully utilized.

The use of de-epithelialized free gingival graft (De-epFGG) as a connective tissue graft (CTG) represents another treatment option for managing gingival recession.

With advancements in laser technology, lasers with various wavelengths are increasingly being used as alternatives to scalpels in numerous intraoral surgical procedures. Considering the advantageous properties of erbium lasers, which are among the most prominent dental lasers, their use has also been demonstrated for preparing recipient sites for free gingival grafts (FGG). There are only a limited number of studies in the literature investigating the combination of De-epithelialized Free Gingival Graft (De-epFGG) with the Tunnel Technique (TT). The aim of this study is to evaluate the clinical effectiveness of SCTG, scalpel-based De-epFGG, and Er,Cr:YSGG laser-based De-epFGG techniques, all applied in combination with the tunnel technique, in the treatment of Miller Class I and II multiple gingival recessions.

The study hypothesis is that the percentage of root coverage achieved using De-epFGG (scalpel and laser methods) would be comparable and that these methods could serve as strong alternatives to SCTG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 52 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Presence of Miller Class I or II recession defects in at least two adjacent teeth in the maxillary or mandibular arch
  • •Recession depth ≥ 2 mm
  • •Recession areas present on intact, caries-free teeth with no restorations

排除标准

  • •▪ History of periodontal surgery in the target area within the past 6 months
  • •Use of antibiotics within the past 6 months
  • •Pregnancy or lactation
  • •Presence of Miller Class III or IV gingival recession
  • •Recession defects on molar teeth
  • •Undergoing orthodontic treatment,
  • •Presence of parafunctional habits
  • •Individuals with contraindications for periodontal surgery were excluded from the study

研究组 & 干预措施

Subepithelial Connective Tissue Grafts Group

Active Comparator

The single incision technique was used as a guide for harvesting the SCTG from the palatal region. After achieving hemostasis in the palatal area, the incision site was primarily closed using 4-0 silk sutures with a cross-suture technique. The graft, held with guide sutures, was slid beneath the interdental papillae and placed into the tunnel bed. The elevated papillary complex was sutured together with the graft using 5-0 monofilament sutures (Neoplene, polypropylene, Turkey) and secured coronally and over the root surface, covering the graft, using vertical double-cross sutures. The surgical procedure, suturing technique, and sutures used on the recipient site were standardized across all groups.

干预措施: Using the tunnel technique in the treatment of gingival recession (Procedure)

•Scalpel-based De-epFGG Group

Active Comparator

In this group, the De-epFGG technique recommended by Zucchelli et al. was applied. The epithelial layer on the outer surface of the harvested graft was removed by holding a 15C scalpel (Swann-Morton LTD, Sheffield, England) parallel to the surface. The prepared CTG was then placed in the tunnel bed at the desired position using guide sutures.

干预措施: Using the tunnel technique in the treatment of gingival recession (Procedure)

Er,Cr:YSGG Laser-based De-epFGG Group

Active Comparator

Before the laser application, patients were asked to wear the necessary protective eyewear. The graft dimensions required for the recipient site were marked on the palatal donor area using a 15C scalpel.

The donor site was irradiated with a 2780 nm Er,Cr:YSGG laser (WaterLase iPlus; USA Biolase Technology Inc., Irvine, CA), and the de-epithelialization procedure was completed intraorally. The surface layer formed as a result of the laser application was removed using a moist sponge.

干预措施: Using the tunnel technique in the treatment of gingival recession (Procedure)

结局指标

主要结局

The percentage of Root Coverage (RCP)

时间窗: Baseline and 6 months

In this study, the difference between the root surface coverage rate in areas with gingival recession was evaluated by subtracting the 6th month recession depth from the pre-treatment recession depth.

Clinical Attachment Level

时间窗: baseline and 6th months

The distance from the mid-buccal point of the teeth to the groove/pocket base based on the cemento-enamel junction was measured in mm with a periodontal probe.

Gingival İndex

时间窗: Baseline and 6th month

Loe ve Silness, 1963 (0-3, skor)

Recession Depth

时间窗: baseline and 6th month

The mid-buccal point of the teeth with gingival recession was measured with a periodontal probe, taking the cemento-enamel junction as the basis, until the coronal part of the gingival margin.

Width of Keratinized Tissue

时间窗: baseline and 6th month

Clinically, it is determined by subtracting the distance between the free gingival margin and the mucogingival line from the distance to the groove/pocket base.

Transgingival Gingival Thickness

时间窗: baseline and 6th month

In this study, gingival thickness was determined by the transgingival probing method.

Plaque Index

时间窗: baseline and 6th month

Silness ve Löe, 1966

Probing Depth

时间窗: baseline and 6th month

Each tooth was measured from the gingival margin to the sulcus base using a periodontal Williams probe, and probing depths were recorded.

次要结局

  • Oral Health Impact Profile-14 and Provoked Sensitivity (PS),(baseline and 6th month)

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazli Zeynep Alpaslan

Associate Professor

Ankara Yildirim Beyazıt University

研究点 (1)

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