Hyaluronic Acid and Free Gingival Graft Healing

August 13, 2023 updated by: Ana Badovinac, University of Zagreb

Impact of Hyaluronic Acid on Free Gingival Graft Healing and Palatal Donor Site Wound Healing

This study aims to evaluate the impact of locally applied hyaluronic acid on free gingival graft wound bed healing and palatal donor site wound healing.

Forty subjects will be randomly divided in two separate groups. Test group will be treated with hyaluronic acid during the procedure and the control group without.

Periodontal parameters and other clinical measurements will be taken on baseline, 7 days postoperative, 14 days postoperative, 1 month, 3 months and 6 months postoperative.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Free gingival graft is common, simple and predictable surgical procedure. Patients who have keratinized tissue width less than 2 mm will undergo the surgery after passing the inclusion criteria together with initial periodontal therapy. Total number of 40 patients will be divided in two separate groups; test group (hyaluronic acid) and control group based on random choice.The randomization will be examiner blind.

After the application of local anaesthesia, surgical procedure will be done in the same groups equally. In the recipient site, an horizontal incision will be performed on the mucogingival junction or 1-2 mm above it to include the free marginal gingiva. Partial thickness flap will be dissected in order to ensure the vascularisation of the graft. The size of the incision and graft will depend on the keratinized tissue width of the teeth area.

The graft will be taken from the donor site on the anterior palate in the area of premolars and molars. The graft will be measured with periodontal probe (UNC-15) in 3 dimensions over the flat surface and after the harvesting will be put in glass with saline. Donor site will be sutured using fibrin sponge and non-resorbable sutures. The size of recipient site and graft will depend on number of teeth with keratinized tissue width less than 2 mm.

The graft will be positioned on the recipient site and stabilised using non-resorbable suture performing single sutures and a sling suture around the tooth. The group of patients who will receive the hyaluronic acid will be treated on donor and recipient site before the suturing, applied once on the wound bed.

Postoperatively, patients will be instructed to rinse with 0.12% chlorhexidine digluconate twice a day. The patients will be asked to keep a diary for 7 days about pain sensations using VAS scale for donor and recipient site. An analgetic treatment will be prescribed if needed.

Recall visits will be 7 and 14 days postoperatively. The 7th day postoperatively will be removed sutures from donor site, and on 14th day the sutures from the graft and recipient site.

Clinical measurements with periodontal indices will be taken on 1, 3, and 6 months follow up.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • no systemic disease
  • healthy
  • non-smokers
  • at least one tooth with keratinized tissue width less than 2 mm

Exclusion Criteria:

  • heavy smokers
  • younger than 18years old
  • using drugs
  • allergy on anesthesia
  • using drugs or alcohol
  • undergoing chemotherapy
  • undergoing radiotherapy

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hyaluronic acid
During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.
Drug: Hyadent BG
Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)
No Intervention: Control

After the harvesting of the graft from the donor site, the wound will be sutured using only saline to clean the wound.

On the recipient site, before positioning the graft, only saline will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized tissue gain
Time Frame: baseline to 1 month postoperatively
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
baseline to 1 month postoperatively
Keratinized tissue gain
Time Frame: baseline to 3 months postoperatively
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
baseline to 3 months postoperatively
Keratinized tissue gain
Time Frame: baseline to 6 months postoperatively
changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction
baseline to 6 months postoperatively
Shrinkage of the graft
Time Frame: baseline to 1 month postoperatively
changes of the graft in apico - coronal and mesio-distal dimensions
baseline to 1 month postoperatively
Shrinkage of the graft
Time Frame: baseline to 3 months postoperatively
changes of the graft in apico - coronal and mesio-distal dimensions
baseline to 3 months postoperatively
Shrinkage of the graft
Time Frame: baseline to 6 months postoperatively
changes of the graft in apico - coronal and mesio-distal dimensions
baseline to 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dimensional changes in gingival recessions
Time Frame: baseline to 1 month postoperative
reduction of gingival recessions
baseline to 1 month postoperative
Dimensional changes in gingival recessions
Time Frame: baseline to 3 months postoperative
reduction of gingival recessions
baseline to 3 months postoperative
Dimensional changes in gingival recessions
Time Frame: baseline to 6 months postoperative
reduction of gingival recessions
baseline to 6 months postoperative

Collaborators and Investigators

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

Sponsor

University of Zagreb

Investigators

  • Study Director: Ana Badovinac, assoc prof, School of Dental Medicine University of Zagreb

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)

March 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-PA-30-V-2/2022.

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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