Back to resultsEffect of Hyaluronic-acid on the Healing After Free Gingival Graft
Primary Purpose
Gingival Recession
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Hyaluronic acid group
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- Clinically diagnosed inadequate attached gingiva
Exclusion Criteria:
- Smoking
Sites / Locations
- Gazi University Faculty of Dentistry Department of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Test Group
Control Group
Arm Description
Hyaluronic acid application group. After FGG was taken from the donor region in the TG, sterile gauze was applied with moderate pressure for 2 minutes, and HA was applied topically after the bleeding stopped. The cross-linked HA package containing 20 mg/ml Na-hyaluronate, stored at room temperature, was opened, and the protective cap of the syringe was removed.
In the control group (CG), HA was not applied to the recipient or the donor site.
Outcomes
Primary Outcome Measures
blood perfusion value in the recipient bed
The comparison of blood perfusion value in the recipient bed between the TG and CG on day 4
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03871218
Brief Title
Effect of Hyaluronic-acid on the Healing After Free Gingival Graft
Official Title
Evaluation of the Effect of Hyaluronic Acid Application on the Healing of the Donor and Recipient Sites After Free Gingival Graft With Laser Doppler Flowmetry
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
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 evaluated the effect of topical hyaluronic acid (HA) application on free gingival graft (FGG) donor and recipient sites during the early wound healing period with laser Doppler flowmetry (LDF) and to investigate the effect of HA application on the dimensional change of the graft.Participants were randomly classified into the test group (TG) and control group (CG). HA was applied to both donor and recipient sites in 20 patients who formed the TG, whereas HA was not applied to the 20 patients who formed the CG.
Detailed Description
The healing of a transplanted tissue depends on the formation of blood support between the donor and recipient sites.
Hyaluronic acid (HA) is a biomaterial that creates a favorable environment for wound healing due to its unique hydroscopic and viscoelastic properties, and it is important for wound healing activities.HA induces angiogenesis following degradation and improves the wound healing environment.HA supports a mechanism that induces proliferation of capillaries, and components produced after HA degradation increase vascularization.Laser Doppler flowmetry (LDF) technique is frequently used in the field of plastic surgery for monitoring microvascular blood flow to detect insufficient circulation in the skin transplants and flaps in the early period and to thereby prevent and predict possible surgical complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
After FGG was taken from the donor region in the TG, sterile gauze was applied with moderate pressure for 2 minutes, and HA was applied topically after the bleeding stopped. In the TG, HA was applied to the entire recipient bed before suturing the graft taken from the palatial mucosa to the recipient site. In the control group (CG), HA was not applied to the recipient or the donor site.
Masking
Outcomes Assessor
Masking Description
examiner blinded
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
Hyaluronic acid application group. After FGG was taken from the donor region in the TG, sterile gauze was applied with moderate pressure for 2 minutes, and HA was applied topically after the bleeding stopped. The cross-linked HA package containing 20 mg/ml Na-hyaluronate, stored at room temperature, was opened, and the protective cap of the syringe was removed.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
In the control group (CG), HA was not applied to the recipient or the donor site.
Intervention Type
Biological
Intervention Name(s)
Hyaluronic acid group
Intervention Description
Applicaton of topical Hyaluronic acid
Primary Outcome Measure Information:
Title
blood perfusion value in the recipient bed
Description
The comparison of blood perfusion value in the recipient bed between the TG and CG on day 4
Time Frame
on day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinically diagnosed inadequate attached gingiva
Exclusion Criteria:
Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Turgut Çankaya
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University Faculty of Dentistry Department of Periodontology
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06510
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Hyaluronic-acid on the Healing After Free Gingival Graft
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