Efficacy of Thyme Honey in The Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial

24-031

Recurrent aphthous stomatitis (RAS) is considered the most common oral mucosal lesion, present first in childhood or adolescence. Aphthous ulcers affect up to 25% of the general population, and 3-month recurrence rates are as high as 50%, it is more common in female, also it increases by increasing age and minor aphthous ulcers are 80% of suffered patient. Due to the antimicrobial, anti-inflammatory, antifungal, and analgesic effects of Thyme honey, and the lack of evidence in the considered population, the present study aimed to assess the effect of honey on the pain relief in patients with minor RAU as a primary objective and to assess the healing effect of natural thyme honey on minor RAU, and the Oral Health Impact Profile (OHIP-14) as a secondary objectives.

2024-05-10

2024-05-15

2024-05-30

Not yet recruiting

20

Inclusion Criteria: * • The study involved patients who had a positive history of having similar oral mucosal ulcers for 3-4 months and ulcers for \<48 h. * Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤5 mm in size in the oral cavity and who gave written consent for participation. * Only single ulcers were considered for the study. * Systemically health patients. Exclusion Criteria: * The study excluded patients with a history of associated systemic disease. * Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous RAS lesions, and smoking. * In addition, no consideration was given to patients with a history of hypersensitivity to honey.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Thyme honey on recurrent aphthous stomatitis', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'the care provider and the outcomes assessor will not know which treatment will be given to the patients.', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-05-20