The effect of Hesperidin mouthwash in comparison with nystatin on patients with Denture Stomatitis: A Clinical Trial

To compare the efficacy of hesperidin and nystatin mouthwashes in reducing lesion size and Candida albicans colony counts in patients with type II denture stomatitis

This is a randomized, controlled, double-blind, two-arm, parallel-group Phase II clinical trial with a target sample size of 24 patients, comprising 12 patients per group. Participants will be individually assigned to receive either hesperidin or nystatin mouthwash using simple randomization generated by the RAND function in Microsoft Excel.

At Tooba Dental Clinic in Sari, consenting patients will be randomized to hesperidin or nystatin mouthwash for two weeks. Lesions will be measured with calipers and photographed weekly; palatal smears and cultures will be obtained before and after treatment. Similar containers will be dispensed by personnel other than the examiner, keeping participants, clinicians, and assessors blinded.

Inclusion criteria: Good general health, use of a removable maxillary denture, type II denture stomatitis confirmed by an oral medicine specialist. Exclusion criteria: Use of antifungals, antibiotics, or corticosteroids within the previous month; nystatin allergy; immunodeficiency; Alzheimer’s disease; psychological or masticatory muscle disorders; inability to use mouthwash; and an ill-fitting or discolored denture.

Intervention group: Hesperidin mouthwash. Control group: Nystatin mouthwash at a concentration of 100,000 units/mL. Both groups will use 20 mL of the assigned mouthwash three times daily for two weeks. Patients will retain the mouthwash in their mouth for one minute per application and avoid eating or drinking for one hour afterward.

Change in denture stomatitis lesion size, assessed by lesion length and width; change in Candida colony growth in culture.

Simple randomization will be performed, with the individual patient as the unit of randomization. A random number between zero and one will be generated for each eligible patient using the RAND function in Microsoft Excel. Patients assigned a number below 0.5 will receive hesperidin mouthwash, whereas those assigned a number of 0.5 or above will receive nystatin mouthwash.

Participants, treating clinicians, and examiners responsible for outcome assessment will be unaware of participants’ group allocation and the mouthwash received. Hesperidin and nystatin mouthwashes will be supplied in containers with similar shape, size, and color. The mouthwashes will be dispensed by personnel other than the examiner so that the person examining and measuring the lesions remains unaware of the assigned treatment.

No further information is available.