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临床试验/NCT04104087
NCT04104087Unknown4 期

The Effect of the Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Deepithelialized Free Gingival Graft on the Papillary Height in the Treatment of RT2 Recession Defect: a Randomized Clinical Trial.

Cairo University0 个研究点目标入组 22 人开始时间: 2019年10月10日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
22
主要终点
the distance between the contact point and the top of the papilla

研究概览

简要总结

Complete coverage of the recession complemented with pleasing esthetics and minimal probing measures are the main goals of root coverage procedures.

According to a consensus report from the AAP regeneration workshop on the periodontal soft tissue root coverage procedures; most studies have been directed on RT-1 (Miller Class I and II) defects and that further research on results in RT-2, RT-3 ( Miller Class III and IV) defects is needed. Consequently, it was planned to conduct this research on RT-2 (Miller Class III) recessions to overcome this gap of knowledge, de-epithelialized free gingival graft is proposed aiming to enhance the papillary height, esthetic, with less pain and postoperative trauma. Equally, it is considered a more conservative approach with fewer complications.

详细描述

Gingival recession has high prevalence among both individuals with periodontal disease and those with high standers of oral hygiene. The management of RT-2 ( Miller Class III) gingival recessions is very challenging and there is controversy in the literature concerning the most predictable approach to treat these defects.

Treatment of gingival recession is performed to enhance esthetics, reduce dentinal hypersensitivity, eliminate caries risk, stop the progression of gingival recession and periodontal attachment loss and keratinized tissue augmentation to enable the patient to maintain adequate plaque control.Gingival recession or "Marginal tissue recession" is recognized as the apical migration of the marginal gingiva to its normal position on the root surface. Connective tissue graft (CTG) is considered to be the best root coverage techniques for the treatment of gingival recession defects.

However, it is challenging sometimes to harvest the largest volume of tissue especially in thin palatal tissue as recently it was recommended to keep 2mm of soft tissue thickness covering the palate to minimize the postoperative pain. Otherwise, necrosis/dehiscence of the flap may happen which was reported to occur frequently for the trap-door approach. Moreover, it is necessary to extend the dissection deeper into the palatal tissues to leave adequate thickness of connective tissue to maintain the vitality of the primary flap which may cause more painful post-operative course.

To overcome these limitations, CTG harvesting with de-epithelialized gingival grafts (DGG) can be executed even in the presence of thin palatal tissues. CTG preparation can be performed more superficially by this approach to obtain collagen-rich connective tissue from Lamina pro- pria of the palatal mucosa. The findings of Zucchelli et al. study support the observation that CTGs which are presumed to have denser connective tissue are comparatively less prone to post-operative shrinkage . According to this assumption, DGG technique may enable to harvest an adequate amount of dense and stable tissue

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)

盲法说明

double

入排标准

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

入选标准

  • Patients 18 years or older. Patients with healthy systemic condition. Buccal recession defects classified as RT-2 recession defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% . No cervical caries or non-carious lesion. No history of periodontal plastic surgery in the affected site

排除标准

  • Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery Unmotivated, uncooperative patients with poor oral hygiene. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.
  • Overlapping teeth or teeth with abnormal alignment in the dental arch.

研究组 & 干预措施

deepithelializ free gingival graft

Experimental

performing tunneling technique with deepithelialized free gingival graft in treating RT2 gingival recession

干预措施: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. (Procedure)

subepithelial connective tissue graft

Active Comparator

performing tunneling technique with sub epithelial connective tissue graft in treating RT2 gingival recession

干预措施: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. (Procedure)

结局指标

主要结局

the distance between the contact point and the top of the papilla

时间窗: 9 months

measuring the distance between the contact point and the top of the papilla by graduated William's periodontal probe

次要结局

未报告次要终点

研究者

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

Sarah Elshourbagy

teaching assistant

Cairo University

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