Clinical Trial

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

Study acronym: HYCHO-TOU
Completed
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07709455
Lead Sponsor Dow University of Health Sciences
Conditions Traumatic Oral Ulceration, Orthodontic Treatment, Orthodontic Appliances, Fixed, Oral Mucosal Ulceration
Enrollment 30 participants
Start Date 2026-01-10
Primary Completion 2026-06-21 (estimated)
Study Completion 2026-06-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-16