Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

• ClinicalTrials.gov Identifier: NCT04265001
• Recruitment Status: Completed
• First Posted: February 11, 2020
• Last Update Posted: February 11, 2020
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mai Zakaria Ibrahium Mohammed, Cairo University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Recurrent Aphthous Stomatitis	Drug: Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
• Primary Purpose: Treatment
• Official Title: Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial
• Actual Study Start Date: November 1, 2019
• Actual Primary Completion Date: January 20, 2020
• Actual Study Completion Date: January 20, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.; Other Name: (Aftamed; Bioplaxpharma, UK)
Experimental: 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.	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.; Other Name: (Aftamed; Bioplaxpharma, UK)

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Ulcer size [ Time Frame: 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.
2. Duration of healing [ Time Frame: one week ]
   period of the ulceration for complete healing

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Faculty of Dentistry, Cairo University

Cairo, Egypt, 115

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Mai Zakaria Ibrahium Mohammed, Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt, Cairo University
• ClinicalTrials.gov Identifier: NCT04265001
• Other Study ID Numbers: Mai Zakaria Ibrahium
• First Posted: February 11, 2020
• Last Update Posted: February 11, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Because the research not published yet.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mai Zakaria Ibrahium Mohammed, Cairo University:

recurrent aphthous stomatitis; chlorhexidine; hyaluronic acid; pain; topical

Additional relevant MeSH terms:

Stomatitis; Stomatitis, Aphthous; Recurrence; Disease Attributes; Pathologic Processes; Mouth Diseases; Stomatognathic Diseases; Hyaluronic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents