CompletedNot Applicable

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

Pakistan30 participantsStarted 2026-01-10

Plain-language 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.

Who can participate

Age range

13 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pain Intensity

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

Trial details

NCT IDNCT07709455

SponsorDow University of Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-21

View on ClinicalTrials.gov More Traumatic Oral Ulceration trials