Hyaluronic Acid in Counteracting Aphthous Stomatitis

Study Overview
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Brief Summary
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Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.

Official Title
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Clinical Evaluation of a Hyaluronic Acid-based Medical Device in Counteracting Aphthous Stomatitis in Adults

Conditions
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Aphthous Stomatitis

Intervention / Treatment
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* Device: Hyaluronic acid-based gel
* Drug: Chlorhexidine Gluconate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of aphthous stomatitis Healthy for other conditions excluding aphthous stomatitis Exclusion Criteria: Taking one of the following in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotic, antifungal, hormone therapy (including birth control pills).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyaluronic acid-based gel<br>The composition of the gel, ranked by weight is: xylitol, glycerin, Rosa damascena petal extract, xanthan gum, polycarbophil, hyaluronic acid sodium salt (0.24%), pectin, potassium sorbate, sodium benzoate, panthenol, Aloe barbadensis leaf extract, stevia. | Device: Hyaluronic acid-based gel<br>* Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks<br>|
| Chlorhexidine gluconate<br>Chlorhexidine gluconate at a concentration of 0.2%. | Drug: Chlorhexidine Gluconate<br>* Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of oral lesions | Change from baseline (Day 1) to Day 14 in the number of oral lesions observed in the two groups | Day 1; Day 3; Day 6; Day 9; Day 12; Day 14 | 
| Change in size of oral lesions | Change from baseline (Day 1) to Day 14 in the size (mm) of oral lesions observed in the two groups | Day 1; Day 3; Day 6; Day 9; Day 12; Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to treatment | Number of daily treatments completed, timing of treatment application (hour of the day) | From Day 1 to Day 14 | 
| Side effects to treatment | Dosage Record Treatment Emergent Symptom Scale (DOTES). It uses a Likert scale, going from 1 (no side effects) to 4 (severe side effects). | From Day 1 to Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosa damascena, mucositis, oral ulcers, chlorhexidine, aloe barbadensis