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临床试验/CTRI/2025/07/091569
CTRI/2025/07/091569尚未招募4 期

Efficacy of recombinant human fibroblast growth factor impregnated scaffold in the management of isolated maxillary gingival recession - A randomised controlled clinical trial

Indian Army1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Changes in recession height

研究概览

简要总结

Recombinant human fibroblast growth factor (rhFGF) has shown promising results in the treatment of isolated maxillary gingival recession defects. When used in conjunction with a coronally advanced flap or biomaterials like collagen membranes, rhFGF enhances angiogenesis, promotes fibroblast proliferation, and accelerates periodontal tissue regeneration. Clinical outcomes demonstrate improved root coverage, increased keratinized tissue width, and superior soft tissue aesthetics, making rhFGF a valuable adjunct in regenerative periodontal therapy for localized recession. However there is no single study available on this in India. Hence this clinical trial.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • RT1 type recession Maxillary gingival recession Isolated gingival recession Thin soft tissue phenotype FMBS less than 20 FMPS less than 20.

排除标准

  • mokers Tobacco users Pregnancy Lactating mothers Not available for 24 months follow up Unwilling for periodic recall every 3 months.

结局指标

主要结局

Changes in recession height

时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Changes in recession width

时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Mean root coverage

时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Complete root coverage

时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Visual analog scale

时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Patient reported outcome measures

时间窗: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

次要结局

  • Patient satisfaction(Incidence of complications)

研究者

发起方
Indian Army
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

DrSaravanan SP

Army Dental Centre Research Referral Delhi

研究点 (1)

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