Hyaluronic Acid in Counteracting Aphthous Stomatitis

Aphthous Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884464
• Other study ID #: UniUrb_HyalAcid_2021
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2021
• Source: University of Urbino "Carlo Bo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Device:
• Hyaluronic acid-based gel
Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks

Drug:
• Chlorhexidine Gluconate
Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks

Locations

Country	Name	City	State
Italy	University fo Urbino Carlo Bo	Urbino

Sponsors (1)

Lead Sponsor	Collaborator
University of Urbino "Carlo Bo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Compliance to treatment	Number of daily treatments completed, timing of treatment application (hour of the day)	From Day 1 to Day 14
Secondary	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