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IRCT20250113064371N1 IRCT 2025-11-14 Babol University of Medical Sciences The effect of Bromelain on recurrent aphthous stomatitis A comparative study on the effect of oral bromelain capsules versus placebo on pain intensity and healing time in patients with recurrent aphthous stomatitis 2025-12-22 anticipated 20 Complete https://irct.ir/trial/81485 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization of the use of oral bromelain capsules or placebo will be alternated, such that patients will be assigned a number based on their order of enrollment in the study (from 1 to 20). Patients with odd numbers (1, 3, 5, etc.) will receive oral bromelain capsules, while those with even numbers (2, 4, 6, etc.) will receive the placebo. In the second phase, the medication not received in the first phase will be administered, Blinding description: Patients will not be informed about their medication (oral bromelain capsules or placebo). The placebo powder will be enclosed in capsules that are identical to the oral bromelain capsules and will be administered to the patients. Both the resident and the specialist in oral diseases will also not be provided with information regarding the type of medication consumed by the patients during the first and second examinations. An external observer (one of the residents specializing in oral diseases) will randomly assign code A or B to the placebo and the oral bromelain capsules, and the patients and researchers will be informed that they belong to group A or B; however, they will not be informed about which group is the intervention group and which is the control group. Ultimately, after the completion of the study and the interpretation of results by the statistical consultant, the external observer will disclose to which group each name belonged. 3 Recurrent Aphthous Stomatitis. Intervention 1: Intervention group: Patients suffering from minor aphthous oral ulcers will be instructed to take one capsule every 12 hours (two capsules per day) on an empty stomach until their oral ulcers have healed. They will also be instructed not to use any alternative methods for alleviation and to avoid consuming irritant foods. All patients will be examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the ulcers occurs at any time prior to these examinations, subsequent assessments will not be conducted. Conversely, should healing not be observed by the seventh day, the use of capsules will continue, and the patient will be re-examined on the tenth day. Intervention 2: Control group: Patients with minor aphthous oral ulcers will be instructed to take one placebo capsule every twelve hours (two capsules per day) on an empty stomach until the healing of their oral ulcers occurs. Additionally, they will be advised to refrain from using other methods for symptom relief and to avoid the consumption of irritant foods. All patients will be examined by a dental specialist on the first, third, fifth, and seventh days, and if complete healing of the ulcers occurs prior to any of these examinations, subsequent examinations will be omitted. In the event that healing has not occurred by the seventh day, the use of the placebo will continue and the patient will be re-evaluated on the tenth day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Upon completion of the study, a written request for permission to publish will be submitted to the Vice President for Research of the university, and upon receiving approval, the data will be published.
public Sobhan Cholaki
Babol University of Medical Sciences, Keshavarz Boulavard, Ganjafrouz Street, Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 cholaki.dent@gmail.com Babol University of Medical Sciences scientific Sobhan Cholaki
Babol University of Medical Sciences, Keshavarz Boulavard, Ganjafrouz Street, Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 cholaki.dent@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) The presence of minor aphthous ulcers in the oral mucosa of the lips or cheeks for a minimum of four episodes per year no limit no limit Both Systemic disease causing oral ulcers History of receiving chemotherapy, immunosuppressants, or corticosteroids within the past year Patients with other mucosal lesions Pregnant and breastfeeding women Patients undergoing treatment with anticoagulant medications Patients whose normal healing of aphthous ulcers typically occurs in less than 5 days. K12.0 Recurrent oral aphthae Treatment - Drugs Placebo Intervention group: Patients suffering from minor aphthous oral ulcers will be instructed to take one capsule every 12 hours (two capsules per day) on an empty stomach until their oral ulcers have healed. They will also be instructed not to use any alternative methods for alleviation and to avoid consuming irritant foods. All patients will be examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the ulcers occurs at any time prior to these examinations, subsequent assessments will not be conducted. Conversely, should healing not be observed by the seventh day, the use of capsules will continue, and the patient will be re-examined on the tenth day. Control group: Patients with minor aphthous oral ulcers will be instructed to take one placebo capsule every twelve hours (two capsules per day) on an empty stomach until the healing of their oral ulcers occurs. Additionally, they will be advised to refrain from using other methods for symptom relief and to avoid the consumption of irritant foods. All patients will be examined by a dental specialist on the first, third, fifth, and seventh days, and if complete healing of the ulcers occurs prior to any of these examinations, subsequent examinations will be omitted. In the event that healing has not occurred by the seventh day, the use of the placebo will continue and the patient will be re-evaluated on the tenth day. Wound area. Timepoint: All patients in both periods are examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the lesions occurs at any time prior to these examinations, subsequent assessments will not be conducted. In the absence of healing by the seventh day, the use of the capsule or placebo will continue, and the patient will be re-examined on the tenth day. Method of measurement: Measurement of the wound diameter in patients will be conducted using an Iwanson gauge with an accuracy of one-tenth of a millimeter, recording both the maximum and minimum diameters. Subsequently, the area of the wound will be calculated using a mathematical formula based on the shape of the wound (circular or elliptical). Pain. Timepoint: All patients in both periods are examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the lesions occurs at any time prior to these examinations, subsequent assessments will not be conducted. In the absence of healing by the seventh day, the use of the capsule or placebo will continue, and the patient will be re-examined on the tenth day. Method of measurement: Pain will be evaluated using the VAS (Visual Analog Scale) as a numerical measure from 0 to 10. For the patient, the number zero will be described as a state of no pain, while the number ten will represent the most severe pain experienced. In order to standardize the pain-inducing stimulus among patients, unsweetened orange juice (single-use) will be utilized. Duration of Recovery. Timepoint: All patients in both periods are examined by a specialist in oral and dental diseases on the first, third, fifth, and seventh days. If healing of the lesions occurs at any time prior to these examinations, subsequent assessments will not be conducted. In the absence of healing by the seventh day, the use of the capsule or placebo will continue, and the patient will be re-examined on the tenth day. Method of measurement: The duration of recovery will be recorded in the patient's file for each period based on pain relief (0=VAS), wound healing, and the absence of any pseudo-membrane, expressed as the number of days. Babol University of Medical Sciences Approved 2025-10-07 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Keshavarz Boulavard, Ganjafrouz Street, Babol Babol Mazandaran Iran (Islamic Republic of)