跳至主要内容
临床试验/NCT05633511
NCT05633511招募中不适用

Volumetric Changes of Soft Tissue Grafting. Comparison of Autologous PRF (Platelet-rich Fibrin ) & Autogenous CTG (Connective Tissue Grafts) . A Split-mouth Randomized Design

Tufts University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月11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
50
试验地点
2
主要终点
Compare autologous PRF & Autogenous CTG

研究概览

简要总结

To correct gum recession, patient's own tissue from the roof of the mouth is harvested and placed where there is root exposed. This is considered gold standard of treatment. Sometimes patient don't want to have second surgical site in their mouth and at the same time do not want to use alternative tissue from human or animal donor. Using patients' blood and preparing it as a membrane is the next best thing to correct gum recession.

详细描述

Patients that are interested in having corrective surgery for recession due to esthetic concerns or sensitivity will be enrolled in the study. The treatment site will randomly receive the procedure assignment. Intraoral scanner will be utilized to establish pre-op volume and will be repeated at each follow up visit. Total of 12 visits and 5 year duration is anticipated for the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Adults 18yrs or older
  • Need of MG-tx for 2 or more sites for root coverage RT I and II (Cairo classification)
  • Class A +/-
  • No class V restoration present

排除标准

  • Patients who do not consent to recommended therapy
  • Patients who smoke
  • Patients who will not be able to comply with follow up protocols
  • Those who self report that they are pregnant.

结局指标

主要结局

Compare autologous PRF & Autogenous CTG

时间窗: 5 years

Primary objective of this study is to compare in a split-mouth study the effectiveness of CTG vs. PRF in soft tissue augmentation and volume stability of each treatment modality in correcting the Cairo Class I, II defects in Periodontally affected patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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