Back to resultsTopical Hyaluronic Acid and Recurrent Aphthous Stomatitis.
Primary Purpose
Recurrent Aphthous Stomatitis
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Aphthous Stomatitis focused on measuring recurrent aphthous stomatitis, chlorhexidine, hyaluronic acid, pain, topical
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.
Sites / Locations
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Hyaluronic acid group (HA group)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Duration of healing
period of the ulceration for complete healing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04265001
Brief Title
Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.
Official Title
Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Aphthous Stomatitis
Keywords
recurrent aphthous stomatitis, chlorhexidine, hyaluronic acid, pain, topical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hyaluronic acid group (HA group)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash
Other Intervention Name(s)
(Aftamed; Bioplaxpharma, UK)
Intervention Description
Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.
Primary Outcome Measure Information:
Title
Pain score
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Ulcer size
Description
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.
Time Frame
one week
Title
Duration of healing
Description
period of the ulceration for complete healing
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
115
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Because the research not published yet.
Learn more about this trial
Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.
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