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
Interventional
Primary Outcome
Pain score
Secondary Outcome
Ulcer size
Condition
Recurrent Aphthous Stomatitis
Intervention
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.
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
Drug
Estimated Enrollment
34
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
disease.
- 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.
Gender
All
Ages
18 Years - 30 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT04265001
Organization ID
Mai Zakaria Ibrahium
Responsible Party
Principal Investigator
Study Sponsor
Cairo University
Study Sponsor
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Verification Date
February 2020