Comparing the effectiveness of photodynamics with laser 810 by Indocyanine green with miconazole on denture stomatitis
Design
This is a randomized,double-blinded clinical trial with a parallel design and a control group. Phase 2-3 this randomized study will be conducted on 40 patients with dentures. A simple random method is used for randomization and the participants are assigned to two intervention groups.
Settings and conduct
This study, which will be conducted in the Faculty of Dentistry of Isfahan Azad University, is a double-blinded one. The researcher and the participants have no role in allocating intervention and control groups. The same researcher evaluates the presence or absence of denture stomatitis based on clinical symptoms and direct observations of the palate mucosa, which is classified into three types according to Newton's suggestion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Patients with dentures and confirmed clinical evidence of denture stomatitis
Exclusion criteria: Patients with a history of diabetes, immunosuppression, radiotherapy, and chemotherapy; Patients who have received antibiotics, antifungal drugs, or steroids in the last 3 months
Intervention groups
In the first intervention group, in addition to miconazole 2% gel that they receive 4 times a day for two weeks, Photodynamics is prepared with light-sensitive green indocyanine at a concentration of 1 mg/ml in sterile distilled water and will be stored in a dark place at room temperature until use. After 10 minutes laser irradiation is performed by an experienced operator using an 810 nm diode laser. The second intervention group will receive miconazole 2% gel 4 times a day for two weeks . For each use, 2.5 ml of gel is applied to the artificial tooth, which is immediately placed in.
Main outcome variables
fungal infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N201
Registration date:2023-06-06, 1402/03/16
Registration timing:prospective
Last update:2023-06-06, 1402/03/16
Update count:0
Registration date
2023-06-06, 1402/03/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of photodynamics with laser810 by Indocyanine green with miconazole on denture stomatitis
Public title
Comparing the effectiveness of photodynamics with laser 810 by Indocyanine green with miconazole on denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Patients with dentures and confirmed clinical evidence of denture stomatitis
Exclusion criteria:
Patients with a history of diabetes, immunosuppression, radiotherapy, and chemotherapy
Patients who have received antibiotics, antifungal drugs or steroids in the last 3 months
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications can only be identified by the serial number on the container. The serials are with the main doctor and will remain confidential until the end of the study. The charge of injecting medications will not know about the assignment of individuals to groups. The participants will not know about the allocation of study groups. Therefore, this study will be a double-blinded one
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-01-07, 1401/10/17
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.331
Health conditions studied
1
Description of health condition studied
Denture Stomatitis
ICD-10 code
K12.1
ICD-10 code description
Other forms of stomatitis
Primary outcomes
1
Description
fungal infection
Timepoint
The beginning and end of the study
Method of measurement
Examination and observation of the dentist
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, in addition to miconazole 2% gel that they receive 4 times a day for two weeks, Photodynamics is prepared with light-sensitive green indocyanine at a concentration of 1 mg/ml in sterile distilled water and will be stored in a dark place at room temperature until use.Then it is placed on the lesion of the palate with a sterile swab, after 10 minutes laser irradiation is performed by an experienced operator using an 810 nm diode laser.
Category
Treatment - Other
2
Description
The second intervention group will receive miconazole 2% gel 4 times a day for two weeks (with a cotton swab placed on the inner surface of the artificial tooth). For each use, 2.5 ml of gel is applied to the artificial tooth, which is immediately placed in.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University, Khorasgan branch
Full name of responsible person
Zahra Khodadadian
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
zakhma3008@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University faculty member
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University faculty member
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Zahra Hadadian
Position
Student of dental
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Kermanshah
Postal code
8155139998
Phone
+98 31 3535 4003
Email
zakhma3008@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Amir Mansour Shirani
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
۷۱۹۳۶۱۳۳۱۱
Phone
+98 31 3535 4003
Email
amir.mansour.shirani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Zahra Hadadian
Position
Student of dental
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4003
Email
zakhma3008@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD