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

NCT04361630 | Completed Early Phase 1

• 1 other identifier: SVSIDS/PERIO/3/2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Gingival Recession; Fibroblast Growth Factor 2; Periodontal Atrophy

Outcome Measures

Primary Outcomes (1)

• Width of keratinized gingiva (wKG)

  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.

  5 months

Study Arms (1)

Main treatment group

EXPERIMENTAL

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

Drug: FGF 2

Interventions

FGF 2 DRUG

Following a standard surgical protocol, rhFGF-2 impregnated membranes will be placed in sites with gingival recession.

Also known as: FGF+Collagen

Main treatment group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Periodontitis; Gingival Recession; Periodontal Atrophy

Interventions

Fibroblast Growth Factor 2

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Single Blinded trial.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)