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临床试验/NCT04611282
NCT04611282已完成不适用

Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial

Istanbul Medipol University Hospital0 个研究点目标入组 17 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
主要终点
Percentage of root coverage

研究概览

简要总结

The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants were:
  • adults aged 18 years or over
  • systemically and periodontally healthy
  • met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme

排除标准

  • Exclusion criteria included the following:
  • medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
  • a history of chemotherapy or radiotherapy;
  • a history of alcoholism or drug abuse;
  • a history of previous mucogingival surgery at the gingival recession site;
  • medications known to affect gingival tissues;
  • antibiotic treatment in the past 6 months;
  • smoking >10 cigarettes per day for >5 years, and;
  • current pregnancy or lactation.

结局指标

主要结局

Percentage of root coverage

时间窗: 6 months

The primary endpoint for efficacy of the gingival recession was the percentage of root coverage at baseline and 6-months postsurgery, as measured by gingival recession depth.

次要结局

  • Changes in Gingival recession width(6 months)
  • visual analog scale(6 months)
  • Changes in Gingival recession depth(6 months)
  • Changes in Keratinized gingival width(6 months)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Begum Alkan

Periodontology specialist

Istanbul Medipol University Hospital

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