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

July 29, 2019 updated by: Zeynep Turgut Çankaya, Gazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

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

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06510
        • Gazi University Faculty of Dentistry Department of Periodontology

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

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically diagnosed inadequate attached gingiva

Exclusion Criteria:

  • Smoking

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
on day 4

Collaborators and Investigators

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

Sponsor

Gazi University

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)

April 1, 2017

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 10, 2019

First Posted (ACTUAL)

March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19.04.2017 08/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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