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临床试验/NCT05664373
NCT05664373招募中不适用

The Use of Coronary Displaced Flap and Deepithelialized Free Graft in the Treatment of Multiple Adjacent Gingival Recessions - A Randomized Controlled Clinical Study

University of Belgrade1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
the presence of the epithelial remnants in the D-FGG grafts

研究概览

简要总结

Successful treatment of multiple gingival recessions (MRG) is a major challenge in periodontal plastic surgery due to complicated predisposing anatomical features of the surrounding tissues, such as a thin gingival phenotype or a limited zone of keratinized gingiva, variations in the depth and width of adjacent gingival recessions, shallow vestibulum and coronally inserted frenums and/or plica.The application of coronary advanced flap (CAF) or tunnel technique (TUN) with connective tissue graft (CTG) gives the best results in the therapy of MRG The application of connective tissue grafts in combination with various surgical techniques is accepted as the "gold standard" in GR therapy. A limitation in the application of CTG is the limited region of the donor site, especially in cases where a larger dimension of the CTG is required, or if the thickness of the hard palate tissue is inadequate. Techniques for obtaining subepithelial CTG (S-CTG), whether it is the trap-door technique or the single incision technique, are often associated with postoperative pain and discomfort, as well as necrosis/dehiscence of the palatal flap at the donor site.

In order to overcome these limitations and obtain a firmer and more uniform CTG, especially when the thickness of the palatal tissue is inadequate (≤2.5 mm) and when a large dimension of the graft in the apico-coronary or mesio-distal direction is required, deepithelialization of the free gingival graft has been proposed (D-FGG). D-FGG has also been shown to be less prone to postoperative contraction, as it consists predominantly of collagen-rich connective tissue from the lamina propria, while adipose/glandular tissue is minimally represented. FGG can be deepithelialized intraorally with a diamond bur or diode laser, or extraorally with a scalpel. Despite all the biological advantages of D-FGG, there is scarce evidence in the literature about its histological characteristics after intraoral and extraoral deepithelialization, as well as the clinical outcomes of grafts thus obtained in combination with CAF in the treatment of MGR. Therefore, this aims of the study are to investigate the clinical efficacy and postoperative patient morbidity using D-FGG and modified CAF in the treatment of MGR, as well as to evaluate the histological characteristics of grafts obtained using two different deepithelialization techniques.

详细描述

This study would be a single-centre, randomized clinical trial (RCT) and would be structured according to the CONSORT statement (http://vvv.consort-statement.org/).

The study would include 50 systemically healthy patients who came to the Clinic for Periodontology and Oral Medicine, School of Dental Medicine, University of Belgrade for the treatment of multiple gingival recessions, and who meet the inclusion criteria.

STUDY DESIGN The study will include patients who voluntarily gave and signed their consent to participate in the research based on written and oral information about the type, duration and expected outcome of the research (document attached).

Split mouth design will be applied in the study. Both sides of the same jaw will be treated using CAF and D-FGG. Immediately before the surgery, using computerized randomization tables,the method of de-epithelialization of the graft will be determined. The contralateral side will be treated no earlier than two months after the first surgical procedure, and FGG will be de-epithelialized using a technique that was not used in the previous intervention.

Clinical examination and initial therapy

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60 years,
  • Non-smokers or consumption of up to 10 cigarettes per day,
  • no signs of gingival inflammation,
  • Presence of at least two single-rooted teeth with type I gingival recession ≥2 mm deep on the buccal side on both sides of the jaw,
  • Plaque index (PI) and gingival bleeding on provocation (BOP) <15% and probing depth (PPD) <3 mm,
  • Absence of non-carious cervical lesions (NCL) and undetectable cemento-enamel junctionr (CEJ) at defect sites,
  • No history of previous periodontal plastic surgery on the affected teeth.

排除标准

  • Presence of carious lesions or restorations in the CEJ area,
  • Use of medications that affect periodontal health and healing,
  • Medical contraindications for periodontal surgical procedures,
  • Pregnancy and breastfeeding.

结局指标

主要结局

the presence of the epithelial remnants in the D-FGG grafts

时间窗: 2 years

The presence of the epithelial remnants in the D-FGG grafts, wich were deepithelialized in different manner, will be histologically assessed

次要结局

  • Root esthetic score (RES)(10 years)
  • Keratinized tissue width(10 years)
  • Gingival thickness(10 years)
  • postsurgery pain assessment(2 months after surgery)
  • Periodontal probing depth (PPD)(10 years)
  • OHIP -14(1 year)
  • Gingival recession depth(10 years)
  • Gingival recession width(10 years)
  • Clinical attachment level(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasa Nikolic Jakoba

Associate Professor

University of Belgrade

研究点 (1)

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