Hyaluronic Acid in Counteracting Aphthous Stomatitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04884464

Enrollment

Registered

2021-05-13

Start date

2018-09-01

Completion date

2019-06-30

Last updated

2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphthous Stomatitis

Keywords

mucositis, oral ulcers, chlorhexidine, aloe barbadensis, rosa damascena

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.

Interventions

DEVICEHyaluronic acid-based gel

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

DRUGChlorhexidine Gluconate

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026