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

NCT07709455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Dow University of Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2026-06-21
Completion
2026-06-28

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709455 on ClinicalTrials.gov