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临床试验/NCT04813081
NCT04813081已完成不适用

The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial

University of Beykent2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2017年5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
32
试验地点
2
主要终点
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times

研究概览

简要总结

The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI).

详细描述

Thirty-two participants were included who were referred to the periodontology clinic suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or tooth/teeth. GOHAI-total and GOHAI psychological impact, functional limitation, pain and discomfort, behavioral impact subcategories were recorded at before and postoperative first week and 30th day. Also, satisfaction questionnaires, number of painkillers and visual analog scale values were recorded.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Non-smoking
  • Teeth and implants with keratinized gingiva width <1 mm
  • A healthy periodontal and peri-implant condition
  • Patients who didn't have ever experience periodontal surgery had first oral surgery experience with dental FGG operation for the first time
  • Patients who underwent implant surgery for the first oral surgery experience
  • Maximum two teeth/implants on recipient area

排除标准

  • Patients receiving any medication to disrupt wound healing
  • Lactation or pregnancy
  • Caries or defects on the tooth root surface
  • Periapical lesion in the recipient area active periodontal disease
  • Patients who have previously had periodontal or oral surgery experiences

结局指标

主要结局

General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times

时间窗: Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.

The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.

次要结局

  • Age(baseline)

研究者

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

Serap Karakış Akcan

Assistant professor doctor

University of Beykent

研究点 (2)

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