Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Gingival Recession Defects

Early Phase 1

Completed

• Conditions: Periodontitis
• Interventions: Drug: FGF 2

• Registration Number: NCT04361630
• Lead Sponsor: SVS Institute of Dental Sciences

Brief Summary

This study was a single-arm trial to obtain preliminary data on the efficacy of collagen membranes impregnated with recombinant human fibroblast growth factor (rhFGF-2) in the treatment of Miller's class I and class II gingival recessions.

Detailed Description

Soft tissues can be regenerated to cover root exposure and a thin biotype can be converted into a thick biotype by using recombinant human growth factor technology. A recent review stated that growth factors could enhance soft tissue regeneration which includes restoration of mucogingival architecture and regeneration of periodontal hard and soft tissues including bone, cementum and periodontal ligament fibers. Fibroblast growth factor-2 (FGF-2), a heparin-binding cytokine with strong angiogenic activity stimulates the proliferation of undifferentiated mesenchymal cells. These functions can be applied in mucogingival surgery as FGF-2 promotes bone and cementum formation and exhibits an increased potential to promote periodontal regeneration in recession defects.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• systemically healthy subjects between 20-55 years presenting with Miller's class I or class II gingival recession[

Exclusion Criteria

• 1. Recessions associated with root demineralization/caries, deep cervical abrasion or pulpal pathology, 2. Patients with history of systemic conditions affecting periodontium and, 3. Smokers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main treatment group	FGF 2	Collagen membranes incorporating 10ng/ml human recombinant basic fibroblast growth factor (FGF-2/bFGF) will be placed in the sites.

Primary Outcome Measures

Name	Time	Method
Width of keratinized gingiva (wKG)	5 months	To assess the wKG, the mucogingival junction was identified visually as the border between the movable (alveolar mucosa) and immovable tissue (gingiva). The distance from the gingival margin to the mucogingival junction was considered as the Wkg.

Trial Locations

Locations (1)

SVS Institute of Dental Sciences, Mahabubnagar; 🇮🇳 Hyderabad, Andhra Pradesh, India