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临床试验/CTRI/2025/09/094157
CTRI/2025/09/094157尚未招募Phase 3 4

Comparison of connective tissue graft(CTG) OR Albumin- platelet rich fibrin (ALB-PRF)with coronally advanced flap in the management of RT1 type gingival recession:A Randomized Control Trial

Self1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
Self
入组人数
20
试验地点
1
主要终点
To assess percentage of root coverage

研究概览

简要总结

Gingival recession is defined as the displacement of marginal gingiva apical to cement-enamel junction causing root exposure. Connective tissue graft (CTG) with coronally advanced flap is currently the gold standard for recession coverage. However, soft tissue graft substitutes are alternative option to autogenous grafts, especially in clinical scenarios  like insufficient tissue to harvest from the palate, the need for multiple surgical procedures to harvest from the same donor site in a short time period, patient morbidity, and medical contraindications to graft harvesting.  Platelets initiate regeneration by releasing growth factors .  Hence platelet rich fibrin has emerged as an interesting surgical additive due to its angiogenesis, immunomodulatory and antimicrobial properties.Several modifications of original platelet rich fibrin (PRF) protocol have been proposed; however, all the membrane generated such as Advanced–PRF(A-PRF) and A-PRF+ have desorption time of only 10-14 days in vivo.A novel technique was proposed by Richard J. Miron in 2020 wherein for 10min platelet poor plasma (PPP) was heated at 750 C causing denaturation and clumping of proteins in gel form to which the upper layer of buffy-coat rich in growth factors was aspirated and mixed with gel to produce albumin PRF (Alb-PRF).  This extended PRF was degraded in 4-6 months,overcoming the drawbacks of previous  PRF membranes formed.In this study the gold standard technique of Coronally advanced flap and  connective tissue graft is compared with coronally advanced flap and Albumin Platelet rich fibrin for management of RT1 Type gingival recession.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • General 1) Plaque score ≤ 20% after phase 1 therapy Site Specific 1) Cairo et.al.
  • RT 1 Type gingival recession 2) ≥ 2mm of keratinized gingiva apical to recession defect.

排除标准

  • Smokers, Pregnant and Lactating mothers, Patients who are not available for follow up.

结局指标

主要结局

To assess percentage of root coverage

时间窗: 4 MONTHS

次要结局

  • To assess Root coverage esthetic score(RES)(4 MONTHS)

研究者

发起方
Self
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Jency George Cheruvathoor

Department of Periodontics Bapuji Dental College and Hospital Davangere

研究点 (1)

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