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IRCT20231209060307N2 IRCT 2024-12-12 Semnan University of Medical Sciences The Effect of Mucosal Micro-needling for Nystatin Delivery in the Treatment of Denture Stomatitis The Effect of Mucosal Micro-needling for Nystatin Delivery in the Treatment of Denture Stomatitis- A Randomized Clinical Trial 2024-11-30 anticipated 10 Complete https://irct.ir/trial/80423 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This research is a randomized clinical trial study on 10 patients who have macular erythematous in the palatal region and have referred to the department of oral diseases of the Faculty of Dentistry with complaints of burning in this part of their mouth, and they were diagnosed with Denture stomatitis by an oral disease specialist in It is considered, it is done. In each patient, one of the left or right side of the lesion is selected as the intervention area and the other side as the control area with a ratio of 1:1. To randomize the sides, 10 cards were prepared with two different options written on them: in 5 cards, the right side was considered as the intervention and the left side was considered as the control, and in the other 5 cards, the left side was considered as the intervention and side Right is defined as control. These cards are placed in separate envelopes and when each patient enters, the ward nurse assigns one of the envelopes to him. The envelopes are randomly distributed from the box prepared for this purpose, so that the allocations are completely random, the envelopes are removed from the box after the selection). 3 Denture stomatitis. Intervention 1: Intervention group: Part of the lesion in the palate where microneedle is applied and nystatin mouthwash is given .The patient is taught to place and hold the microneedle on a randomly selected side for one minute and then use nystatin suspension (Two full droppers at each turn for two minutes 3 times a day).The microneedling used in this study has a height of 600, a base of 300 and a distance between the needles of 500 micrometers. have been made. Intervention 2: Control group: Part of the lesion in the palate where only nystatin mouthwash is given.(Two full droppers at each turn for two minutes 3 times a day). Yes - There is a plan to make this available What will be shared: All the data obtained from the participants will be shared under the title of Microneedling plan patients When: After 6 months, the results will be printed To whom: The data will be available to researchers working in academic and scientific institutions Conditions: Any kind of qualitative and quantitative analysis on the data for research work by the researchers in this field is unobstructed Where to obtain: Dr. Nahid Karbasi -Semnan Faculty of Dentistry How to obtain: After sending the application by e-mail and reviewing the researcher's resume, the documents will be sent to the individual within 6 months. Comments:
public Nahid Karbasi
Shahrivar(17) St
Semnan Iran (Islamic Republic of) 3671674569 +98 23 3522 6200 Sov.karbasi@gmail.com Semnan University of Medical Sciences scientific Nahid Karbasi
Shahrivar(17) St
Semnan Iran (Islamic Republic of) 3671674569 +98 23 3522 6200 Sov.karbasi@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Have informed consent to participate in the study. They use complete and partial upper jaw dentures. People who have bilateral involvement of the lesion with a width of at least 2 cm. 25 years no limit Both Addiction to cigarettes and drugs History of allergy to antifungals such as nystatin Pregnant or lactating people Volunteers who have adverse drug reactions (such as an allergic reaction to any drug) Patients with uncontrolled systemic diseases B37.0 Candidal stomatitis Treatment - Devices Treatment - Drugs Intervention group: Part of the lesion in the palate where microneedle is applied and nystatin mouthwash is given .The patient is taught to place and hold the microneedle on a randomly selected side for one minute and then use nystatin suspension (Two full droppers at each turn for two minutes 3 times a day).The microneedling used in this study has a height of 600, a base of 300 and a distance between the needles of 500 micrometers. have been made. Control group: Part of the lesion in the palate where only nystatin mouthwash is given.(Two full droppers at each turn for two minutes 3 times a day) Healing the lesion caused by the denture. Timepoint: At the beginning of the study and after 5 and 10 days. Method of measurement: By visual inspection (0- Absence of denture stomatitis 1-mild redness 2-moderate to severe redness 3-granular surface). Semnan University of Medical Sciences Approved 2024-10-14 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services 17 Shahrivar St Semnan Semnan Iran (Islamic Republic of)