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

Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Absorbable Collagen Membrane With Coronally Advanced Flap In Class I And II Gingival Recession Defects -A Randomized Control Trial

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04361630

Enrollment

Registered

2020-04-24

Start date

2019-05-01

Completion date

2019-12-01

Last updated

2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

Gingival Recession, Fibroblast Growth Factor 2, Periodontal Atrophy

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.

Interventions

DRUGFGF 2

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Masking description

Single Blinded trial.

Intervention model description

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026