Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

NCT ID: NCT04265001

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-01-20

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.

Conditions

Recurrent Aphthous Stomatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.

Hyaluronic acid group (HA group)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.

Interventions

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

Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.

Intervention Type: DRUG

Other Intervention Names

(Aftamed; Bioplaxpharma, UK)

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Zakaria Ibrahium Mohammed

Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Mai Zakaria Ibrahium

Identifier Type: -

Identifier Source: org_study_id