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Completed

NCT Number: NCT04361630

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

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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Key information

Conditions

Periodontitis Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FGF 2

Drug

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

Other names: FGF+Collagen

Primary outcomes

  1. Width of keratinized gingiva (wKG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

SVS Institute of Dental Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2020
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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