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NCT Number: NCT07689695

MOUTHRİNSES AND PALATAL DONOR SİTE HEALİNG AFTER FREE GİNGİVAL GRAFT

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.

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Key information

Conditions

Palatal Donor Site Wound Healing Periodontal Plastic Surgery

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University Faculty of Dentistry

Van, Tuşba, 65100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypochlorous Acid

Drug

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.

Hyaluronic Acid (HA)

Drug

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.

Chlorhexidine gluconate 0.2%

Drug

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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