Hyaluronic Acid in Counteracting Aphthous Stomatitis

NCT ID: NCT04884464

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aphthous Stomatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Hyaluronic acid-based gel

Intervention Type DEVICE

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%.

Chlorhexidine Gluconate

Intervention Type DRUG

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

Interventions

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Hyaluronic acid-based gel

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

Intervention Type DEVICE

Chlorhexidine Gluconate

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Urbino "Carlo Bo"

OTHER

Sponsor Role lead

Responsible Party

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Davide Sisti

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davide Sisti, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Urbino "Carlo Bo"

Locations

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University fo Urbino Carlo Bo

Urbino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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UniUrb_HyalAcid_2021

Identifier Type: -

Identifier Source: org_study_id

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