MOUTHRİNSES AND PALATAL DONOR SİTE HEALİNG AFTER FREE GİNGİVAL GRAFT

NCT07689695 | Completed

• 1 other identifier: FGG-RCT-2021-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Plastic Surgery; Palatal Donor Site Wound Healing

Keywords

Free gingival graft; Hypochlorous acid; Hyaluronic acid; Chlorhexidine; Palatal wound healing; Soft tissue healing

Outcome Measures

Primary Outcomes (1)

• Palatal donor site wound healing assessed using the Wound Healing Index (WHI)

  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

Study Arms (3)

Hypochlorous Acid Mouthrinse

EXPERIMENTAL

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

Hyaluronic Acid Mouthrinse

EXPERIMENTAL

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)

0.2% Chlorhexidine Mouthrinse

ACTIVE COMPARATOR

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%

Interventions

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.

Hypochlorous Acid Mouthrinse

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.

Hyaluronic Acid Mouthrinse

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.

0.2% Chlorhexidine Mouthrinse

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University Faculty of Dentistry

Van, Tuşba, 65100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Hypochlorous Acid; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Hacer Şahin Aydınyurt, DDS, PhD

  Van Yuzuncu Yil University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical examiner responsible for all outcome assessments was blinded to treatment allocation throughout the study. Participant blinding was not feasible because the mouthrinses differed in packaging, appearance, and taste. All clinical measurements were performed by the same blinded examiner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned to one of three parallel groups receiving hypochlorous acid, hyaluronic acid, or 0.2% chlorhexidine mouthrinse following free gingival graft surgery.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: June 20, 2020
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)