Back to resultsRecombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Gingival Recession Defects
Primary Purpose
Periodontitis
Status
Completed
Phase
Early Phase 1
Locations
India
Study Type
Interventional
Intervention
FGF 2
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis focused on measuring Gingival Recession, Fibroblast Growth Factor 2, Periodontal Atrophy
Eligibility Criteria
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.
Sites / Locations
- SVS Institute of Dental Sciences, Mahabubnagar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main treatment group
Arm Description
Collagen membranes incorporating 10ng/ml human recombinant basic fibroblast growth factor (FGF-2/bFGF) will be placed in the sites.
Outcomes
Primary Outcome Measures
Width of keratinized gingiva (wKG)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04361630
First Posted
April 22, 2020
Last Updated
April 29, 2020
Sponsor
SVS Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04361630
Brief Title
Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Gingival Recession Defects
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Gingival Recession, Fibroblast Growth Factor 2, Periodontal Atrophy
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Single Blinded trial.
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Main treatment group
Arm Type
Experimental
Arm Description
Collagen membranes incorporating 10ng/ml human recombinant basic fibroblast growth factor (FGF-2/bFGF) will be placed in the sites.
Intervention Type
Drug
Intervention Name(s)
FGF 2
Other Intervention Name(s)
FGF+Collagen
Intervention Description
Following a standard surgical protocol, rhFGF-2 impregnated membranes will be placed in sites with gingival recession.
Primary Outcome Measure Information:
Title
Width of keratinized gingiva (wKG)
Description
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.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
SVS Institute of Dental Sciences, Mahabubnagar
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
509002
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current plans to share data with other researchers.
Learn more about this trial
Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Gingival Recession Defects
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