Comparison of Hyaluronic Acid and Chlorhexidine Gels for Traumatic Oral Ulcers During Fixed Orthodontic Treatment

NCT07709455 | Completed DMC

• 1 other identifier: DIKIOHS-ORTHO-TOU-2026-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Oral Ulceration; Orthodontic Treatment; Orthodontic Appliances, Fixed; Oral Mucosal Ulceration

Keywords

Oral mucosal ulcer; Fixed orthodontic appliances; Orthodontic treatment; Traumatic oral ulcer; Wound healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Ulcer Size

  Baseline (Day 1), Day 3, and Day 7 after initiation of treatment

• Clinical Healing of Traumatic Oral Ulcers

  Baseline (Day 1), Day 3, and Day 7 after initiation of treatment

Study Arms (2)

Hyaluronic Acid Gel

EXPERIMENTAL

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

Chlorhexidine Gel

ACTIVE COMPARATOR

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

Interventions

Hyaluronic Acid gel DRUG

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.

Hyaluronic Acid Gel

Chlorhexidine gel DRUG

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.

Chlorhexidine Gel

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences (DUHS)

Karachi, Pakistan

Location

MeSH Terms

Conditions

Oral Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Participants who develop traumatic oral ulcers following placement of fixed orthodontic appliances will be randomly assigned in a 1:1 ratio to receive either topical hyaluronic acid gel or topical chlorhexidine gel. Participants will remain in their assigned treatment group throughout the 7-day follow-up period.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: January 10, 2026
• Primary Completion: June 21, 2026
• Study Completion: June 28, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)