Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Recurrent Aphthous Stomatitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04265001

Mai Zakaria Ibrahium

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Control group

Active Comparator 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.

Treatment:

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

Hyaluronic acid group (HA group)

Experimental group

Description:

Topical hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash (Aftamed; Bioplaxpharma, UK).Topical hyaluronic acid mouthwash treatment has been repeated three times per day for one week.

Treatment:

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