Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
- Conditions
- Recurrent Aphthous Stomatitis
- Sponsor
- Cairo University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Pain score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Mai Zakaria Ibrahium Mohammed
Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt
Cairo University
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.
Arms & Interventions
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.
Intervention: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
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.
Intervention: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
Outcomes
Primary Outcomes
Pain score
Time Frame: 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 Outcomes
- Ulcer size(one week)
- Duration of healing(one week)