Hyaluronic Acid in Counteracting Aphthous Stomatitis
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Hyaluronic acid-based gel 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
Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks
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Chlorhexidine gluconate Chlorhexidine gluconate at a concentration of 0.2%. |
Drug: Chlorhexidine Gluconate
Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks
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Outcome Measures
Primary Outcome Measures
- Change in number of oral lesions [Day 1; Day 3; Day 6; Day 9; Day 12; Day 14]
Change from baseline (Day 1) to Day 14 in the number of oral lesions observed in the two groups
- Change in size of oral lesions [Day 1; Day 3; Day 6; Day 9; Day 12; Day 14]
Change from baseline (Day 1) to Day 14 in the size (mm) of oral lesions observed in the two groups
Secondary Outcome Measures
- Compliance to treatment [From Day 1 to Day 14]
Number of daily treatments completed, timing of treatment application (hour of the day)
- Side effects to treatment [From Day 1 to Day 14]
Dosage Record Treatment Emergent Symptom Scale (DOTES). It uses a Likert scale, going from 1 (no side effects) to 4 (severe side effects).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of aphthous stomatitis
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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).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University fo Urbino Carlo Bo | Urbino | Italy | 61029 |
Sponsors and Collaborators
- University of Urbino "Carlo Bo"
Investigators
- Principal Investigator: Davide Sisti, PhD, University of Urbino "Carlo Bo"
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UniUrb_HyalAcid_2021