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临床试验/CTRI/2025/08/093282
CTRI/2025/08/093282尚未招募4 期

Gingival phenotypic modification using recombinant human fibroblast growth factor -2 impregnated scaffold - A randomised 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10月15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 gingival soft tissue height Changes in keratinised tissue width

研究概览

简要总结

Recombinant human fibroblast growth factor incorporated into a collagen scaffold offers a biomimetic, cell-stimulating alternative to autogenous connective tissue graft for gingival soft tissue phenotype modification. While connective tissue graft remains the gold standard for increasing gingival thickness and keratinized tissue width due to its predictable integration and volume stability, it is associated with donor site morbidity and limited tissue availability. rhFGF collagen scaffolds eliminate the need for a second surgical site and actively promote fibroblast proliferation, angiogenesis, and extracellular matrix deposition, potentially achieving comparable gains in gingival thickness with reduced patient morbidity. However, long term clinical evidence is still more robust for connective tissue grafts and rhFGF collagen scaffolds are currently better positioned as minimally invasive regenerative adjuncts rather than full  replacements. Hence this clinical trial is planned to be conducted with this rationale and background.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Thin gingival phenotype Mandibular anterior region with respect to central incisors FMBS less than 20 FMPS less than 20.

排除标准

  • Smokers Tobacco users Pregnancy Lactating mothers Not available for 12 months follow up Unwilling for periodic recall every 3 months.

结局指标

主要结局

Changes in gingival soft tissue height Changes in keratinised tissue 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(0,3,6,9,12 months)

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

Dr Saravanan SP

Army Dental Centre Research Referral Delhi

研究点 (1)

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