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临床试验/CTRI/2024/06/069312
CTRI/2024/06/069312已完成Phase 3 4

Root coverage with tunneled coronally advanced flap (TCAF) Versus vestibular incisional subperiosteal tunnel access (VISTA) in combination with connective tissue graft (CTG) in multiple adjacent gingival recession: A Randomized Controlled Trial

Dr. Payoshni kalamkar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
To compare complete root coverage (CRC) in multiple adjacent gingival recessions at baseline ,3 months ,6 months after surgery using TCAF vs VISTA technique in combination with CTG.

研究概览

简要总结

Gingival recession is the exposure of the root surface resulting from migration of the gingival margin apical to the cemento-enamel junction(CEJ)1.Multiple adjacent gingival recession (MAGR) is common and various techniques have been described for its treatment,[e.g. Coronally advanced flap (CAF)2,tunnel technique (TUN)3,Envelope flap designs adjuncts [e.g., free gingival graft (FGG), connective tissue graft(CTG),enamel matrix derivatives (EMD)4, soft tissue substitutes(STS) membranes for guided tissue regeneration (GTR)5,etc. and combinations there-of have been tried. The coronally advanced flap (CAF)2and the tunnel technique (TUN)3are the most performed surgical approaches for treating gingival recessions (GRs). Nonetheless, these two approaches have commonly been regarded as substitutes for one another, and clinicians are often faced with the choice of performing only one during root coverage procedures. The aim is to describe a surgical design in which the benefits of both the CAF and the TUN are combined for the treatment.

Vestibular incisional subperiosteal tunnel access (VISTA) is a minimally invasive approach to treat multiple gingival recession, some studies are done with combination of CTG, PRF with VISTA which gives better result in reduction of gingival recession. TCAF technique is introduced by Dr. Shayan Barootchi and Dr. Lorenzo Tavelli, in 2022, it is specifically designed for soft tissue grafting via the Coronally Advanced Flap (CAF), the Tunnel approach (TUN), and their combination (TCAF). Very few articles are published on this technique which concluded potential of TCAF technique to enhance flap blood supply and graft vascularization and improve clinical, esthetic, and patient-reported outcomes compared with conventional surgical techniques.

There are no enough studies that compare tunneled coronally advanced flap (TCAF) vs vestibular incisional subperiosteal access (VISTA) for treatment of adjacent multiple gingival recession. Therefore, this study is aimed to evaluate the efficacy and performance of TCAF technique vs VISTA technique in treatment of multiple adjacent 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 and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Systemically healthy patients with age between 18 and 60 yrs.
  • 2.At least 20 natural teeth should be present.
  • 3.At least two adjacent Millers class I and II / Cairo RT1 recession defects from 2nd premolar right side to 2nd premolar left side in maxillary and mandibular arches.
  • 5.Patients with esthetic concerns.
  • 6.Identifiable CEJ or CEJ of a contralateral homologous tooth or adjacent teeth is used to replicate the lost CEJ.
  • 7.Patients willing to participate and willing to sign an informed consent.

排除标准

  • 1.Systemic conditions and diseases that could affect the progression of periodontal disease.
  • 2.Patients those who underwent any subgingival periodontal therapy or antibiotic therapy in past 6 months.
  • 3.Patients using smokeless as well as smoking form of tobacco.
  • 4.Pregnant and lactating females.
  • 6.Patients with recently undergone Orthodontic treatment.
  • 7.Patients with prosthesis on the teeth with recession.

结局指标

主要结局

To compare complete root coverage (CRC) in multiple adjacent gingival recessions at baseline ,3 months ,6 months after surgery using TCAF vs VISTA technique in combination with CTG.

时间窗: baseline,3months , 6 months

次要结局

  • To compare clinical parameters like Recession depth(RD), recession width(RW),Mean Root Coverage (MRC), keratinized tissue width (KTW),Width of attached gingiva (WAG),Root coverage esthetic score (RES),at baseline,3 months, 6 months. Patient related outcome measure- Visual analogue scale(VAS),in multiple adjacent gingival recessions at first week, second week after surgery,using TCAF vs VISTA in combination with CTG . And Time of procedure for both groups.(baseline, 3 months , 6 months)

研究者

发起方
Dr. Payoshni kalamkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nihal Devkar

Sinhgad dental college and hospital

研究点 (1)

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