Hyaluronic Acid in Counteracting Aphthous Stomatitis

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Brief Title

Hyaluronic Acid in Counteracting Aphthous Stomatitis

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Change in number of oral lesions

Secondary Outcome

 Compliance to treatment

Condition

Aphthous Stomatitis

Intervention

Hyaluronic acid-based gel

Study Arms / Comparison Groups

 Hyaluronic acid-based gel
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

49

Start Date

September 1, 2018

Completion Date

June 30, 2019

Primary Completion Date

June 30, 2019

Eligibility Criteria

        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).
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Davide Sisti, PhD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04884464

Organization ID

UniUrb_HyalAcid_2021


Responsible Party

Principal Investigator

Study Sponsor

University of Urbino "Carlo Bo"


Study Sponsor

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


Verification Date

July 2021