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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Single Blinded trial.

Study Groups

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Main treatment group

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

Group Type EXPERIMENTAL

FGF 2

Intervention Type DRUG

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

Interventions

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FGF 2

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

Intervention Type DRUG

Other Intervention Names

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FGF+Collagen

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No