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Clinical Trials/CTRI/2025/08/093282
CTRI/2025/08/093282Not yet recruitingPhase 4

Gingival phenotypic modification using recombinant human fibroblast growth factor -2 impregnated scaffold - A randomised clinical trial

Indian Army1 site in 1 country30 target enrollmentStarted: October 15, 2025Last updated:

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

Sponsor
Indian Army
Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Dr Saravanan SP

Army Dental Centre Research Referral Delhi

Study Sites (1)

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