Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Aphthous Stomatitis

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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. | Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash<br>* Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.<br>* Other names: (Aftamed; Bioplaxpharma, UK);|
| Experimental: Hyaluronic acid group (HA group)<br>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. | Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash<br>* Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.<br>* Other names: (Aftamed; Bioplaxpharma, UK);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Duration of healing | period of the ulceration for complete healing | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent aphthous stomatitis, chlorhexidine, hyaluronic acid, pain, topical