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临床试验/CTRI/2022/09/045303
CTRI/2022/09/045303已完成不适用

Comparative Evaluation of Coronally Advanced Flap with and without Chorionic Membrane in the Treatment of Isolated Gingival Recession: A Randomized Controlled Trial.

Dr Geddam Navya1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年12月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Recession height,

研究概览

简要总结

Gingival recession is the “apical migration of the gingival margin below the cemento-enamel junction (CEJ).†It is a multifactorial disease commonly caused by the accumulation of plaque biofilm resulting in inflammatory periodontal diseases and due to trauma caused by faulty and aggressive tooth brushing.  The coronally advanced flap (CAF) is a commonly used method for root coverage, and it has demonstrated very good results in treating gingival recessions regarding root coverage and esthetic outcomes. They possess antimicrobial and antibacterial properties and have shown to reduce inflammation and provide a protein-rich matrix, thereby facilitating the migration of cells at the defect area. Yadav K et al in 2015, concluded that, Chorionic membrane provides an effective alternative to autograft tissue in the treatment of shallow-to-moderate Miller’s Class I and II recession defects. In addition, the self adherent nature of the amniotic membrane significantly reduced surgical time and easier to perform. Chorion membrane has shown to reduce scar formation and inflammation, enhancing healing of the wound. Its matrix contains growth factors such as keratinocyte growth factor, basic fibroblast growth factor, and transforming growth factor-b, which help in regenerating the periodontium and gives a setting for faster healing.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Subjects who are diagnosed with Millers Class- I and Class-II gingival recession in anterior teeth and premolars, Subjects aged between 18-45 years of both sexes, Subjects who are willing to participate in the study.

排除标准

  • Participants who had undergone any mucogingival procedures at the selected sites within the previous 3 months, Subjects with any known disease or intake of any medication that affects periodontal status, Molar teeth and teeth with poor periodontal prognosis, Subjects allergic to local anesthesia and chlorhexidine (CHX), antibiotic, and analgesic which would be prescribed, Subjects with Aggressive periodontitis, Current Smokers and Alcoholics, Pregnant or Lactating females, Subjects who are not willing to participate in the study.

结局指标

主要结局

Recession height,

时间窗: At baseline and 6 months

Recession width,

时间窗: At baseline and 6 months

Clinical attachment loss,

时间窗: At baseline and 6 months

width of keratinized gingiva

时间窗: At baseline and 6 months

次要结局

  • Gingival tissue thickness, Complete root coverage and Mean root coverage.(At baseline 1 month and 6 months)

研究者

发起方
Dr Geddam Navya
申办方类型
Other [self]

研究点 (1)

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