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临床试验/NCT05563428
NCT05563428招募中不适用

Efficacy of Free Gingival Graft Versus Connective Tissue Graft in the Treatment of Gingival Recessions at the Lower Incisors: a RCT

Centre Hospitalier Universitaire de Liege2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9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
40
试验地点
2
主要终点
Digital mean root coverage

研究概览

简要总结

This study wil compare FGG and CTG for recession coverage in the anterior mandibula.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA type I and II subjects
  • Localized Gingival Recessions
  • Recessions Cairo RT I-II-III
  • FMPS < 10%
  • FMBS< 10%
  • <10 cigs/ day
  • No contra-indication against oral surgical interventions
  • Patient is able to give inform consent

排除标准

  • Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
  • ASA type > II
  • Current pregnancy or breastfeeding women
  • Alcoholism or chronically drug abuse
  • Smokers, ≳ 10 cigarettes per day
  • Immunocompromised patients
  • Uncontrolled diabetes
  • Untreated periodontitis
  • History of previous periodontal surgery (mucogingival or other) on the teeth to be included
  • Presence of severe tooth malposition, rotation or significant version of the tooth to be treated
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability

结局指标

主要结局

Digital mean root coverage

时间窗: Baseline, 3 months, 6 months and up to 10 years after surgery

Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline.

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

Isabelle Laleman

Chef de clinique

Centre Hospitalier Universitaire de Liege

研究点 (2)

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