Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

Phase 3

Completed

• Conditions: Recurrent Aphthous Stomatitis
• Interventions: Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash

• Registration Number: NCT04265001
• Lead Sponsor: Cairo University

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 Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-01-20
• Study Completion: 2020-01-20
• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash	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.
Hyaluronic acid group (HA group)	Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash	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.

Primary Outcome Measures

Name	Time	Method
Pain score	one week	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.

Secondary Outcome Measures

Name	Time	Method
Ulcer size	one week	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.
Duration of healing	one week	period of the ulceration for complete healing

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt