Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

Recurrent Aphthous Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265001
• Other study ID #: Mai Zakaria Ibrahium
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2019
• Est. completion date: January 20, 2020

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrent Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome) after irritation of the ulcer with the periodontal probe.	one week
Secondary	Ulcer size	The ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.Score for clinical improvement of the sign where high values indicate worse outcome but low values indicate better outcome.	one week
Secondary	Duration of healing	period of the ulceration for complete healing	one week