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临床试验/NCT05460182
NCT05460182已完成不适用

Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results

University of Florence2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Complete Root Coverage (CRC)

研究概览

简要总结

Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.

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)

盲法说明

Two examiners, blinded with respect to the surgical procedures, assessed all the clinical and aesthetic outcomes of treatments.

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

  • Smoking < 20 cigarettes/day.
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth).
  • Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession > 2 mm of depth
  • Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
  • Presence of an identifiable CEJ

排除标准

  • Systemic diseases or pregnancy.
  • Systemic antibiotic therapy in the last 6 months.
  • Active periodontal disease with sites showing probing depth >4 mm.

结局指标

主要结局

Complete Root Coverage (CRC)

时间窗: After the intervention (10 years)

Complete Root Coverage: absence of gingival recession (Yes/No)

次要结局

  • Recession Reduction (RecRed)(After the intervention (10 years))
  • Root Coverage Aesthetic Score (RES)(After the intervention (10 years))

研究者

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

Dr. Francesco Cairo

Prof.

University of Florence

研究点 (2)

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