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

S

SVS Institute of Dental Sciences

Status and phase

Completed
Early Phase 1

Conditions

Periodontitis

Treatments

Drug: FGF 2

Study type

Interventional

Funder types

Other

Identifiers

NCT04361630
SVSIDS/PERIO/3/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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