Hyaluronic Acid in Counteracting Aphthous Stomatitis

Completed

• Conditions: Aphthous Stomatitis
• Interventions: Drug: Chlorhexidine Gluconate; Device: Hyaluronic acid-based gel

• Registration Number: NCT04884464
• Lead Sponsor: University of Urbino "Carlo Bo"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chlorhexidine gluconate	Chlorhexidine Gluconate	Chlorhexidine gluconate at a concentration of 0.2%.
Hyaluronic acid-based gel	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
Compliance to treatment	From Day 1 to Day 14	Number of daily treatments completed, timing of treatment application (hour of the day)

Trial Locations

Locations (1)

University fo Urbino Carlo Bo; 🇮🇹 Urbino, Italy