跳至主要内容
临床试验/CTRI/2024/07/071448
CTRI/2024/07/071448尚未招募不适用

A comparative clinical evaluation of the treatment outcomes of an autologus fibroblast seeded volume stable collagen matrix vs volume stable collagen matrix alone in class I and class II gingival recession defects.

Dr Devapriyan S Ragas dental college and hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
RD-recession depth

研究概览

简要总结

Gingival recession is defined as exposure of the root surface or the apical shift of the gingival margin from the cemento-enamel junction( CEJ) with a multifactorial etiology, leading to hypersensitivity. Gingival fibroblasts are known to play a critical role in periodontal wound healing and regeneration. The  autogenous connective tissue graft (CTG) is considered as the gold standard in the  management of gingival  recession, but the associated donor site morbidity hinders its widespread  applicability. Since then, allogenic and xenogenic collagen matrices have found its way in the repertoire of various periodontal treatment modalities for gingival management. The purpose of this trial is to study the clinical efficacy of one such volume stable collagen matrix (Fibro-Gide)which  is of xenogenic in origin, resorbable  and specifically designed for soft-tissue regeneration. It is made of reconstituted collagen and undergoes smart chemical cross-linking to improve its volume stability while maintaining a good biocompatibility. The study also aims to study and compare the above matrix with autologous fibroblast seeded on to it in the treatment of class I class II gingival recession defects, wherein the fibroblasts are known to  have an  important role in the  regeneration of periodontal ligament along with the  volume stable collagen matrix ( Fibro-Gide) which further supports angiogenesis, formation of new connective tissue and stability of the collagen network in the surrounding soft-tissue.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • •18 to 40 years of age Systemically healthy patient Patients having Class I/II gingival recession Patients exhibiting good oral hygiene.

排除标准

  • •Pregnant and Lactating women.
  • •Medically compromised patients.
  • •Patients with known history of allergy.

结局指标

主要结局

RD-recession depth

时间窗: Base line | 1 month | 3 month | 6 month

RW-recession width

时间窗: Base line | 1 month | 3 month | 6 month

complete root coverage (CRC)

时间窗: Base line | 1 month | 3 month | 6 month

次要结局

  • WKT-Width of Keratinized Tissue(KT-Keratinized Tissue Thickness)

研究者

发起方
Dr Devapriyan S Ragas dental college and hospital
申办方类型
Other [Private Dental College and Hospital ]

研究点 (1)

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