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.

Traumatic oral ulcers are among the most common adverse effects experienced during fixed orthodontic treatment. They usually occur due to continuous mechanical irritation of the oral mucosa by orthodontic brackets, archwires, or other appliance components. These lesions may cause pain, interfere with mastication and speech, and reduce patient comfort and compliance with orthodontic treatment. Although traumatic ulcers generally heal spontaneously after removal of the source of irritation, topical agents are frequently prescribed to accelerate healing and relieve symptoms.

Hyaluronic acid is a naturally occurring glycosaminoglycan with anti-inflammatory, tissue regenerative, and wound-healing properties. It promotes cell migration, angiogenesis, and extracellular matrix formation, thereby facilitating mucosal repair while reducing pain and inflammation. Chlorhexidine gel is a widely used topical antiseptic that reduces bacterial colonization of oral wounds and helps prevent secondary infection during the healing process. Although both agents are commonly used in dental practice, evidence directly comparing their effectiveness in the management of orthodontic traumatic oral ulcers remains limited.

This study is designed as a single-center, parallel-group, randomized controlled trial conducted in the Department of Orthodontics, DIKIOHS. Thirty patients aged 13-35 years who develop traumatic oral ulcers following placement of fixed orthodontic appliances and meet the eligibility criteria will be enrolled. Participants will be randomly assigned in a 1:1 ratio using the lottery method to receive either topical hyaluronic acid gel or topical chlorhexidine gel.

Participants in both groups will be instructed to apply approximately a grain-sized amount of the assigned gel directly onto the ulcer using a clean finger or cotton swab three times daily for seven consecutive days. They will be advised to avoid eating, drinking, or rinsing immediately after application to maximize contact time with the lesion.

Clinical assessments will be performed at baseline (Day 1), Day 3, and Day 7. At each visit, ulcer location, clinical appearance, ulcer size (measured in millimeters using a transparent ruler), and pain intensity (measured using a Visual Analog Scale) will be recorded. The primary outcome will be reduction in pain intensity, while secondary outcomes will include reduction in ulcer size and clinical healing over the seven-day treatment period.

The findings of this study are expected to provide evidence regarding the comparative effectiveness of hyaluronic acid gel and chlorhexidine gel for the treatment of traumatic oral ulcers associated with fixed orthodontic appliances. The results may assist orthodontists in selecting the most effective topical treatment to improve patient comfort, promote faster healing, and enhance adherence to orthodontic treatment.

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.