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Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265001
Recruitment Status : Completed
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mai Zakaria Ibrahium Mohammed, 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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

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)




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04265001


Locations
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Egypt
Faculty of Dentistry, Cairo University
Cairo, Egypt, 115
Sponsors and Collaborators
Cairo University
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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    Key Record Dates
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.

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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:
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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