Hyaluronic Acid in Counteracting Aphthous Stomatitis

Sponsor

University of Urbino "Carlo Bo" (Other)

Overall Status

Completed

CT.gov ID

NCT04884464

Collaborator

(none)

Enrollment

Location

9.9

Actual Duration (Months)

4.9

Patients Per Site Per Month

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
Aphthous Stomatitis	Device: Hyaluronic acid-based gel Drug: Chlorhexidine Gluconate

Study Design

Study Type:

Observational

Actual Enrollment :

49 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

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

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).