Gingival phenotypic modification using recombinant human fibroblast growth factor -2 impregnated scaffold - A randomised clinical trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in gingival soft tissue height Changes in keratinised tissue width
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 35.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Thin gingival phenotype Mandibular anterior region with respect to central incisors FMBS less than 20 FMPS less than 20.
Exclusion Criteria
- •Smokers Tobacco users Pregnancy Lactating mothers Not available for 12 months follow up Unwilling for periodic recall every 3 months.
Outcomes
Primary Outcomes
Changes in gingival soft tissue height Changes in keratinised tissue width
Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Mean root coverage
Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Complete root coverage
Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Visual analog scale
Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Patient reported outcome measures
Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Secondary Outcomes
- Patient satisfaction Incidence of complications(0,3,6,9,12 months)
Investigators
Dr Saravanan SP
Army Dental Centre Research Referral Delhi
