MOUTHRİNSES AND PALATAL DONOR SİTE HEALİNG AFTER FREE GİNGİVAL GRAFT

July 1, 2026 updated by: Kübra Eskin, Yuzuncu Yil University

COMPARİSON OF HYPOCHLOROUS ACİD, HYALURONİC ACİD, AND CHLORHEXİDİNE MOUTHRİNSES ON PALATAL DONOR SİTE HEALİNG FOLLOWİNG FREE GİNGİVAL GRAFT SURGERY: A SİNGLE-BLİND CONTROLLED CLİNİCAL TRİAL

This single-blind randomized controlled clinical trial aimed to compare the effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses on palatal donor site healing following free gingival graft surgery. Fifty-four patients requiring free gingival graft surgery were randomly assigned to one of three mouthrinse groups. Clinical wound healing, wound dimensions, epithelialization, tissue consistency, bleeding control, and postoperative pain were evaluated during a 28-day follow-up period. The findings of this study may contribute to the identification of an effective postoperative mouthrinse for improving palatal donor site healing and patient comfort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Free gingival graft (FGG) surgery is a well-established periodontal procedure for increasing the width of keratinized tissue. Healing of the palatal donor site is often associated with postoperative pain and patient discomfort. Various mouthrinses have been proposed to improve wound healing and reduce postoperative symptoms; however, evidence comparing hypochlorous acid, hyaluronic acid, and chlorhexidine is limited.

This single-blind, parallel-group, randomized controlled clinical trial was conducted to compare the effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses on palatal donor site healing following FGG surgery. Fifty-four participants requiring FGG surgery were randomly allocated to one of three intervention groups. Clinical assessments included wound dimensions, wound healing index, epithelialization, tissue consistency, bleeding control, and postoperative pain using a visual analogue scale. Participants were followed for 28 days after surgery. The primary objective was to evaluate the effect of each mouthrinse on palatal donor site healing and postoperative recovery.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

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 (Türkiye)
    • Tuşba
      • Van, Tuşba, Turkey (Türkiye), 65100
        • Van Yuzuncu Yil University Faculty of Dentistry

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 55 years.
  • Indication for free gingival graft surgery to increase keratinized tissue width.
  • Systemically healthy individuals.
  • Palatal donor site suitable for graft harvesting.
  • No history of periodontal surgery within the previous six months.
  • Ability and willingness to comply with postoperative instructions and follow-up visits.
  • Provision of written informed consent.

Exclusion Criteria:

  • Systemic diseases that could affect wound healing.
  • Smoking.
  • Antibiotic use within the previous six months.
  • Pregnancy or lactation.
  • Known hypersensitivity to chlorhexidine, hypochlorous acid, hyaluronic acid, or any component of the study products.
  • Active oral infection, periodontal abscess, or poor oral hygiene.
  • Previous palatal surgery, mucosal lesions, anatomical limitations, or conditions affecting hemostasis at the donor site.
  • Inability or unwillingness to comply with the study protocol.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypochlorous Acid Mouthrinse
Participants received a commercially available hypochlorous acid mouthrinse (Crystalin®, NHP İlaç San. ve Tic. A.Ş., Ankara, Türkiye). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery.
Drug: Hypochlorous Acid
Commercially available hypochlorous acid mouthrinse (Crystalin®, NHP İlaç San. ve Tic. A.Ş., Ankara, Türkiye). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery.
Experimental: Hyaluronic Acid Mouthrinse
Participants received a commercially available hyaluronic acid mouthrinse (Gengigel®, Ricerfarma, Milan, Italy). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery.
Drug: Hyaluronic Acid (HA)
Commercially available hyaluronic acid mouthrinse (Gengigel®, Ricerfarma, Milan, Italy). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery.
Active Comparator: 0.2% Chlorhexidine Mouthrinse
Participants received a commercially available 0.2% chlorhexidine gluconate mouthrinse (Kloroben®, Drogsan, Ankara, Türkiye). Participants were instructed to rinse with 15 mL for 60 seconds, three times daily for 14 days, beginning 24 hours after free gingival graft surgery.
Drug: Chlorhexidine gluconate 0.2%
Commercially available 0.2% chlorhexidine gluconate mouthrinse (Kloroben®, Drogsan, Ankara, Türkiye). Participants rinsed with 15 mL for 60 seconds three times daily for 14 days beginning 24 hours after free gingival graft surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palatal donor site wound healing assessed using the Wound Healing Index (WHI)
Time Frame: 28 days after surgery
Wound healing was evaluated using the Wound Healing Index (WHI) following free gingival graft surgery. The index was used to compare the healing effects of hypochlorous acid, hyaluronic acid, and chlorhexidine mouthrinses.
28 days after surgery

Collaborators and Investigators

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

Sponsor

Yuzuncu Yil University

Investigators

  • Principal Investigator: Hacer Şahin Aydınyurt, DDS, PhD, Van Yuzuncu Yil University Faculty of Dentistry

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)

June 20, 2020

Primary Completion (Actual)

July 7, 2021

Study Completion (Actual)

July 7, 2021

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGG-RCT-2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because participant consent for public data sharing was not obtained at the time of enrollment, and the dataset contains information that could potentially compromise participant confidentiality.

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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