跳至主要内容
临床试验/CTRI/2024/06/068416
CTRI/2024/06/068416招募中Phase 3 4

De-epithelialized Free Gingival Graft Versus Subepithelial Connective Tissue Graft in the treatment of multiple adjacent gingival recessions using Modified Coronally Advanced Tunnel Technique: A Randomized Controlled Trial.

Dr Snehal Pudke1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年2月7日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
19
试验地点
1
主要终点
(CRC) percentage in multiple adjacent gingival recessions (Millers class I

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 cementoenamel junction (CEJ).Multiple adjacent gingival recession(MAGR) is common and various techniques have been described for the its treatment [e.g., coronally advanced flap (CAF), tunnel technique (TUN), flap designs (e.g., CAF with/without vertical releasing incisions, TUN with/without split-flap, etc.), adjuncts [e.g., free gingival graft (FGG), connective tissue graft (CTG), enamel matrix derivatives (EMD), soft tissue substitutes (STS) membranes for guided tissue regeneration (GTR), etc.], and combinations thereof have been tried. Most systematic reviews conclude that CAF + CTG should be considered as the ‘gold standard’ for single Miller class I and II GR, also coined as recession type (RT1). Recent literature indicate that tunnel technique (TUN) is a highly effective and predictable procedure in the treatment of multiple Gingival Recession (GR) defects. Positive outcomes of root coverage with TUN might be attributed to inherent advantage of this approach being a minimally invasive procedure with limited flap opening and lack of vertical releasing incisions, all of which contribute to decreased tissue trauma, enhanced wound healing, and greater blood supply to the graft. (Azzi & Etienne 1998, Zuhr et al. 2007, Aroca et al. 2010). Tunnel technique was first introduced by Allen in 1994, and its modifications by Zabalegui in 1999, Modified Coronally Advanced Tunnel (MCAT) by Azzi et al 2002 and Microsurgical CAT by Zuhr 2007. Over the following years, additional modifications of MCAT technique were proposed, such as introduction of the microsurgical approach, full-thickness flap preparation, papillae detachment and elevation, modified suturing technique, application of collagen porcine dermal matrix in lieu of SCTG , inclusion of biological factors such as enamel matrix derivative (EMD) or concentrated growth factor (CGF) , and site-specific application of Sub-epithelial connective tissue graft (SCTG). Various techniques have been proposed to obtain SCTG. Recently, de-epithelialized free gingival graft (FGG) has been used as another method to obtain SCTG. Therefore, the aim of this split mouth randomized controlled study is to evaluate and compare de-epithelialized FGG or SCTG in the treatment of multiple adjacent gingival recessions using MCAT.

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

  • Systemically healthy patients with age between 18 and 60 yrs.
  • At least 20 natural teeth should be present.
  • At least two adjacent Millers class I and II or Cairo’s RT1 recession defects from 2nd premolar right side to 2nd premolar left side in maxillary and mandibular arches.
  • Minimum depth of gingival recession defect should be ≥ 2mm.
  • Patients with healthy periodontal conditions.
  • Patients with esthetic concerns.
  • Patients willing to participate and willing to sign an informed consent.

排除标准

  • Systemic conditions and diseases that could affect the progression of periodontal disease.
  • Patients those who underwent any subgingival periodontal therapy or antibiotic therapy in past 6 months.
  • Patients using smokeless as well as smoking form of tobacco.
  • Pregnant and lactating females.

结局指标

主要结局

(CRC) percentage in multiple adjacent gingival recessions (Millers class I

时间窗: Baseline and 6 months after surgery

To compare the complete/extent of root coverage

时间窗: Baseline and 6 months after surgery

and II or Cairo’s RT1) at baseline and 6 months after surgery using MCAT

时间窗: Baseline and 6 months after surgery

technique with de-epithelialized FGG and MCAT with SCTG

时间窗: Baseline and 6 months after surgery

次要结局

  • To compare clinical parameters like Mean root(coverage (MRC) , Keratinized tissue width (KTW), Gingival recession depth)

研究者

发起方
Dr Snehal Pudke
申办方类型
Other [self]

研究点 (1)

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