Gingival phenotypic modification using recombinant human fibroblast growth factor -2 impregnated scaffold - A randomised clinical trial
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
Dr Saravanan SP
Army Dental Centre Research Referral Delhi
