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

April 29, 2020 updated by: Dr R Viswa Chandra, SVS Institute of Dental Sciences

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 509002
        • SVS Institute of Dental Sciences, Mahabubnagar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Main treatment group
Collagen membranes incorporating 10ng/ml human recombinant basic fibroblast growth factor (FGF-2/bFGF) will be placed in the sites.
Drug: FGF 2
Following a standard surgical protocol, rhFGF-2 impregnated membranes will be placed in sites with gingival recession.
Other Names:
  • FGF+Collagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SVS Institute of Dental Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVSIDS/PERIO/3/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No current plans to share data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on FGF 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe