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Effect of Hyaluronic-acid on the Healing After Free Gingival Graft

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ClinicalTrials.gov Identifier: NCT03871218
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Zeynep Turgut Çankaya, Gazi University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gingival Recession Biological: Hyaluronic acid group Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: examiner blinded
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : December 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Test Group
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.
 Biological: Hyaluronic acid group
Applicaton of topical Hyaluronic acid
No Intervention: Control Group
In the control group (CG), HA was not applied to the recipient or the donor site.


Outcome Measures
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Primary Outcome Measures :
  1. blood perfusion value in the recipient bed [ Time Frame: on day 4 ]
    The comparison of blood perfusion value in the recipient bed between the TG and CG on day 4


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinically diagnosed inadequate attached gingiva

Exclusion Criteria:

  • Smoking
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871218


Locations
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Turkey
Gazi University Faculty of Dentistry Department of Periodontology
Ankara, Çankaya, Turkey, 06510
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Zeynep Turgut Çankaya Gazi University
More Information
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Responsible Party: Zeynep Turgut Çankaya, Principal Investigator, Gazi University
ClinicalTrials.gov Identifier: NCT03871218    
Other Study ID Numbers: 19.04.2017 08/14
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents