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COMPLETED
NCT07709455
NA

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

Sponsor: Dow University of Health Sciences

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.

Official title: 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

Key Details

Gender

All

Age Range

13 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-10

Completion Date

2026-06-28

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Dow University of Health Sciences (DUHS)

Karachi, Pakistan