In this study, the effect of mucosal microneedling to transfer nystatin in the treatment of denture stomatitis is investigated
Design
This research is a randomized clinical trial study on 10 patients who have macular erythematous in the palatal area and have referred to the oral diseases department of the dental faculty. 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 .For randomization from 10 separate cards It was used with two options, right or left.
Settings and conduct
Patients referring to Semnan Dental Faculty are taught to place and hold the microneedle on a randomly selected side for one minute, and then use nystatin suspension (two full drips each time for two minutes, 3 times a day). to use And after 5 and 10 days, go to the dentist for follow-up.
The final year student, who has passed the criteria for diagnosing lesions and received practical training, examines the samples according to the severity of the existing lesions based on the clinical examination method. In this way, the patient's mouth is examined and recorded for the presence or absence of denture stomatitis and its severity (0 absence of denture stomatitis, 1 mild redness, 2 moderate to severe redness, and 3 granular level).
Participants/Inclusion and exclusion criteria
Inclusion criteria :They use complete and partial upper jaw dentures
Exclusion criteria :Smoking and drug addiction .History of allergy to antifungals such as nystatin
Intervention groups
People who have a 2-cm-wide denture stomatitis lesion were selected and the lesion was divided into two parts, and in each patient, one of the left or right side of the lesion in the palate was selected as the intervention area and the other side as the control area with an allocation ratio of 1:1.
Main outcome variables
The effect of microneedle on the intensity of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231209060307N2
Registration date:2024-12-12, 1403/09/22
Registration timing:registered_while_recruiting
Last update:2024-12-12, 1403/09/22
Update count:0
Registration date
2024-12-12, 1403/09/22
Registrant information
Name
Amirhosein Moghaddasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3522 6200
Email address
amirhoosh1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-30, 1403/09/10
Expected recruitment end date
2025-02-28, 1403/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mucosal Micro-needling for Nystatin Delivery in the Treatment of Denture Stomatitis- A Randomized Clinical Trial
Public title
The Effect of Mucosal Micro-needling for Nystatin Delivery in the Treatment of Denture Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 25 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
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).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University Of Medical Sciences and Health Services
Street address
17 Shahrivar St
City
Semnan
Province
Semnan
Postal code
3671674569
Approval date
2024-10-14, 1403/07/23
Ethics committee reference number
IR.SEMUMS.REC.1403.199
Health conditions studied
1
Description of health condition studied
Denture stomatitis
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis
Primary outcomes
1
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Semnan University of Medical Sciences
Full name of responsible person
Nahid Karbasi
Street address
Shahrivar(17) St
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
Dent@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Jalili
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
Info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nahid Karbasi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahrivar(17) St
City
Semnan
Province
Semnan
Postal code
3671674569
Phone
+98 23 3522 6200
Fax
Email
Sov.karbasi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nahid Karbasi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahrivar(17) St
City
Semnan
Province
Semnan
Postal code
3671674569
Phone
+98 23 3522 6200
Fax
Email
Sov.karbasi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Amirhosein Moghaddasi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Bahonar(7) St-number1
City
Damghan
Province
Semnan
Postal code
3671674569
Phone
+98 23 3522 6200
Fax
Email
Amirhoosh1378@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data obtained from the participants will be shared under the title of Microneedling plan patients
When the data will become available and for how long
After 6 months, the results will be printed
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any kind of qualitative and quantitative analysis on the data for research work by the researchers in this field is unobstructed
From where data/document is obtainable
Dr. Nahid Karbasi -Semnan Faculty of Dentistry
What processes are involved for a request to access data/document
After sending the application by e-mail and reviewing the researcher's resume, the documents will be sent to the individual within 6 months.