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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Chlorhexidine gluconate | Chlorhexidine gluconate at a concentration of 0.2%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid-based gel | Device | Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects without ethnic limitations, of both sexes and between the ages of 18 and 65, with a diagnosis of aphthous stomatitis, but considered otherwise healthy.
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| Name | Affiliation | Role |
|---|---|---|
| Davide Sisti, PhD | University of Urbino "Carlo Bo" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University fo Urbino Carlo Bo | Urbino | 61029 | Italy |
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| ID | Term |
|---|---|
| D013281 | Stomatitis, Aphthous |
| D052016 | Mucositis |
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Chlorhexidine Gluconate | Drug | Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks |
|
| From Day 1 to Day 14 |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |