Hyaluronic Acid in Counteracting Aphthous Stomatitis

July 21, 2021 updated by: Davide Sisti, University of Urbino "Carlo Bo"

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Urbino, Italy, 61029
        • University fo Urbino Carlo Bo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult subjects without ethnic limitations, of both sexes and between the ages of 18 and 65, with a diagnosis of aphthous stomatitis, but considered otherwise healthy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of oral lesions
Time Frame: 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
Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Change in size of oral lesions
Time Frame: 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
Day 1; Day 3; Day 6; Day 9; Day 12; Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to treatment
Time Frame: From Day 1 to Day 14
Number of daily treatments completed, timing of treatment application (hour of the day)
From Day 1 to Day 14
Side effects to treatment
Time Frame: 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).
From Day 1 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Urbino "Carlo Bo"

Investigators

  • Principal Investigator: Davide Sisti, PhD, University of Urbino "Carlo Bo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniUrb_HyalAcid_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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