Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

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Brief Title

Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

Official Title

Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial

Brief Summary

      This study was conducted to estimate the hypothesis that the topical hyaluronic acid
      mouthwash have no role in the treatment of recurrent aphthous stomatitis

Detailed Description

      Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the
      oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting
      ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red
      halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50%
      every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are
      as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic,
      immunological, and psychological factors.

Study Phase

Phase 3

Study Type


Primary Outcome

Pain score

Secondary Outcome

 Ulcer size


Recurrent Aphthous Stomatitis


Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash

Study Arms / Comparison Groups

 Control group
Description:  Topical cholrhexidine hydrochloride 125 mg/100 ml available commercially (Hexitol; Arab Drug Company for Pharmaceutical and Chemical Industries, Cairo, Egypt) mouthwash. Topical cholrhexidine hydrochloride mouthwash treatment has been repeated three times per day for one week.


* 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


Estimated Enrollment


Start Date

November 1, 2019

Completion Date

January 20, 2020

Primary Completion Date

January 20, 2020

Eligibility Criteria

        Inclusion Criteria:

        The inclusion criteria were as follows:

          -  Age 18-30 years.

          -  Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent
             aphthous stomatitis.

        Exclusion Criteria:

          -  known history of hypersensitivities to Chlorhexidine or hyaluronic acid.

          -  Use of any medication as a treatment for the present active ulcer.

          -  Smoking and presence of systemic diseases such as Behçet disease, anemia, Crohn's
             disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney

          -  Pregnant or breast-feeding women.

          -  Stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus.

          -  Treatment with systemic nonsteroidal anti-inflammatory drugs, systemic steroids or
             other immune modulatory agents, oral antihistamines, or systemic antibiotics in the
             previous 3 months.




18 Years - 30 Years

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID

Mai Zakaria Ibrahium

Responsible Party

Principal Investigator

Study Sponsor

Cairo University

Study Sponsor

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Verification Date

February 2020