跳至主要内容
临床试验/NCT05851248
NCT05851248招募中不适用

Free Mucogingival Graft for Isolated Root Coverage and Correct Unfavorable Mucogingival Conditions in Lower Incisors: A Randomized Clinical Trial

Universidad de Murcia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
buccal Recession (bREC)

研究概览

简要总结

The goal of this clinical trial is to to describe and evaluate an approach, free mucogingival graft (FMG), in periodontal plastic surgery for root coverage (RC) in lower incisor gingival recessions (GR) with mucogingival conditions and deformities (MCD) that might negatively influence the outcomes of conventional RC procedures.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patients with deep GR associated with lower incisor MCD.
  • Full mouth plaque and bleeding scores were <20%.

排除标准

  • Patient characteristics:
  • Smoking ≥10 cigarettes a day.
  • Medications or systemic contraindications for oral surgery.
  • Pregnancy.
  • Thin scalloped biotype (AND/OR)
  • Underlying bone dehiscence (AND /OR)
  • Generalized GR affecting most sextants.

研究组 & 干预措施

Buccal muco-gingival tissue graft

Experimental

干预措施: Buccal muco-gingival tissue graft (Procedure)

Palatal connective tissue graft

Active Comparator

干预措施: Palatal connective tissue graft (Procedure)

结局指标

主要结局

buccal Recession (bREC)

时间窗: 12 months

Buccal recession measurement, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.

次要结局

  • vestibule depth (VD)(12 months)
  • buccal Clinical Attachment Level (bCAL)(12 months)
  • interproximal Clinical Attachment Level (iCAL)(12 months)
  • Interproximal papilla tip location (PT)(12 months)
  • keratinized tissue width (KT)(12 months)
  • Soft tissue attached to alveolar bone (STAB)(12 months)

研究者

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

Antonio José Ortiz Ruiz, MD

Professor and Researcher

Universidad de Murcia

研究点 (1)

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