Comparison of Hyaluronic Acid and Chlorhexidine Gels for Traumatic Oral Ulcers During Fixed Orthodontic Treatment (HYCHO-TOU)

Comparison of the Effectiveness of Hyaluronic Acid Gel and Chlorhexidine Gel in the Treatment of Traumatic Oral Ulcers Following Fixed Orthodontic Appliance Therapy: A Randomized Controlled Trial

This randomized controlled trial aims to compare the effectiveness of topical hyaluronic acid gel and chlorhexidine gel in the management of traumatic oral ulcers that develop following placement of fixed orthodontic appliances. Traumatic oral ulcers are a common complication of orthodontic treatment and may cause significant pain, discomfort, and difficulty with eating and speaking, potentially affecting patient compliance with treatment.

A total of 30 eligible patients who develop traumatic oral ulcers after placement of fixed orthodontic appliances will be randomly allocated to receive either hyaluronic acid gel or chlorhexidine gel. Participants will be instructed to apply the assigned gel three times daily for seven days. Clinical evaluations will be performed at baseline (Day 1), Day 3, and Day 7 to assess ulcer size and pain intensity using a Visual Analog Scale (VAS). The study will compare changes in pain and ulcer healing between the two treatment groups to determine which gel provides superior clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Orthodontic Treatment; Orthodontic Appliances, Fixed; Oral Mucosal Ulceration; Traumatic Oral Ulceration
• Intervention / Treatment: Drug: Hyaluronic Acid gel; Drug: Chlorhexidine gel

Detailed Description

Traumatic oral ulcers are among the most common adverse effects experienced during fixed orthodontic treatment. They usually occur due to continuous mechanical irritation of the oral mucosa by orthodontic brackets, archwires, or other appliance components. These lesions may cause pain, interfere with mastication and speech, and reduce patient comfort and compliance with orthodontic treatment. Although traumatic ulcers generally heal spontaneously after removal of the source of irritation, topical agents are frequently prescribed to accelerate healing and relieve symptoms.

Hyaluronic acid is a naturally occurring glycosaminoglycan with anti-inflammatory, tissue regenerative, and wound-healing properties. It promotes cell migration, angiogenesis, and extracellular matrix formation, thereby facilitating mucosal repair while reducing pain and inflammation. Chlorhexidine gel is a widely used topical antiseptic that reduces bacterial colonization of oral wounds and helps prevent secondary infection during the healing process. Although both agents are commonly used in dental practice, evidence directly comparing their effectiveness in the management of orthodontic traumatic oral ulcers remains limited.

This study is designed as a single-center, parallel-group, randomized controlled trial conducted in the Department of Orthodontics, DIKIOHS. Thirty patients aged 13-35 years who develop traumatic oral ulcers following placement of fixed orthodontic appliances and meet the eligibility criteria will be enrolled. Participants will be randomly assigned in a 1:1 ratio using the lottery method to receive either topical hyaluronic acid gel or topical chlorhexidine gel.

Participants in both groups will be instructed to apply approximately a grain-sized amount of the assigned gel directly onto the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. They will be advised to avoid eating, drinking, or rinsing immediately after application to maximize contact time with the lesion.

Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. At each visit, ulcer location, clinical appearance, ulcer size (measured in millimeters using a transparent ruler), and pain intensity (measured using a Visual Analog Scale) will be recorded. The primary outcome will be reduction in pain intensity, while secondary outcomes will include reduction in ulcer size and clinical healing over the seven-day treatment period.

The findings of this study are expected to provide evidence regarding the comparative effectiveness of hyaluronic acid gel and chlorhexidine gel for the treatment of traumatic oral ulcers associated with fixed orthodontic appliances. The results may assist orthodontists in selecting the most effective topical treatment to improve patient comfort, promote faster healing, and enhance adherence to orthodontic treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • Dow University of Health Sciences (DUHS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria Male or female patients aged 13 to 35 years. Patients undergoing treatment with fixed orthodontic appliances. Development of a clinically diagnosed traumatic oral ulcer within the study period following placement or adjustment of fixed orthodontic appliances.

Presentation within 24 hours of ulcer development. Good oral hygiene with no active untreated dental caries. Healthy periodontal condition without clinical signs of gingivitis or periodontitis.

Willingness to comply with the study protocol, attend follow-up visits, and provide written informed consent (or parental/guardian consent for participants younger than 18 years).

Exclusion Criteria Use of medications known to interfere with wound healing, including systemic corticosteroids, immunosuppressive agents, anticoagulants, or chemotherapy.

Current smokers or users of smokeless tobacco products. History of recurrent aphthous stomatitis or other chronic oral ulcerative disorders.

Presence of oral mucosal diseases such as pemphigus vulgaris, bullous disorders, erosive lesions, or oral lichen planus.

Systemic diseases that may impair wound healing or manifest with oral ulceration.

Oral ulcerations of non-traumatic or unknown origin. Known hypersensitivity or allergy to hyaluronic acid, chlorhexidine, or any component of the study gels.

Presence of active oral infection requiring antimicrobial treatment. Inability or unwillingness to comply with study procedures or scheduled follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic Acid Gel; Participants randomized to this arm will receive topical hyaluronic acid gel within 24 hours of developing a traumatic oral ulcer following placement of fixed orthodontic appliances. They will be instructed to apply approximately a grain-sized amount of the gel directly to the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7.	Drug: Hyaluronic Acid gel; Participants assigned to this intervention will apply topical hyaluronic acid gel directly to the traumatic oral ulcer within 24 hours of ulcer development following placement of fixed orthodontic appliances. Approximately a grain-sized amount of the gel will be applied using a clean finger or cotton swab three times daily for seven consecutive days. Participants will be instructed to avoid eating, drinking, or rinsing immediately after application.
Active Comparator: Chlorhexidine Gel; Participants randomized to this arm will receive topical chlorhexidine gel within 24 hours of developing a traumatic oral ulcer following placement of fixed orthodontic appliances. They will be instructed to apply approximately a grain-sized amount of the gel directly to the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7.	Drug: Chlorhexidine gel; Participants assigned to this intervention will apply topical chlorhexidine gel directly to the traumatic oral ulcer within 24 hours of ulcer development following placement of fixed orthodontic appliances. Approximately a grain-sized amount of the gel will be applied using a clean finger or cotton swab three times daily for seven consecutive days. Participants will be instructed to avoid eating, drinking, or rinsing immediately after application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	Pain intensity associated with traumatic oral ulcers will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded at baseline (Day 1), Day 3, and Day 7 to compare pain reduction between the hyaluronic acid gel and chlorhexidine gel groups.	Baseline (Day 1), Day 3, and Day 7 after initiation of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ulcer Size	The greatest diameter of the traumatic oral ulcer will be measured in millimeters using a transparent ruler at each follow-up visit. Changes in ulcer size over time will be compared between the treatment groups to evaluate wound healing.	Baseline (Day 1), Day 3, and Day 7 after initiation of treatment
Clinical Healing of Traumatic Oral Ulcers	Clinical healing will be assessed by evaluating the reduction in ulcer size and changes in the clinical appearance of the lesion, including epithelialization, reduction in erythema, and resolution of the ulcer, during the 7-day treatment period.	Baseline (Day 1), Day 3, and Day 7 after initiation of treatment

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2026
• Primary Completion (Actual): June 21, 2026
• Study Completion (Actual): June 28, 2026

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Wound healing; Orthodontic treatment; Fixed orthodontic appliances; Oral mucosal ulcer; Traumatic oral ulcer
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Oral Ulcer
• Other Study ID Numbers: DIKIOHS-ORTHO-TOU-2026-01

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