Determining the effect of a combined mouthwash of triamcinolone acetonide 0.1% and Q10 coenzyme in the treatment of oral lichen planus
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized
Settings and conduct
This study is performed on patients with oral lichen planus referred to the Oral Patients Department of Shahid Beheshti Dental School. In this study, the researcher and the patient will not know the type of drugs (double-blind), and patient examination and evaluation of oral lesions are done by one person before and after the treatment.
Participants/Inclusion and exclusion criteria
Patients with symptomatic oral lichen planus.
Inclusion criteria: The diagnosis is clinical and in cases in which a definitive diagnosis of the lesion is difficult, a histopathological evaluation will be used.
The patient should not have used topical corticosteroid treatments in the last two weeks or systemic corticosteroids in the last month.
and also should not have used analgesics and anesthetics.
Exclusion criteria: Patients with lichenoid lesions caused by medication or dental materials, Pregnant or lactating patients, Patients with other lesions such as leukoplakia and systemic lupus in conjunction with lichen planus, History of malignancy, Non-cooperative patients, and patients who do not use drugs
Intervention groups
One group of patients receive 0.1% triamcinolone mouthwash and the other group receives triamcinolone and coenzyme Q10 combined mouthwash. mouthwash will be used four times a day in the amount of 15 ml each time (by the measure) and then patients shouldn't eat or drink anything for half an hour. The mouthwash should be gargled in the mouth for two minutes.
The patients will be Instructed how to use mouthwash.
Main outcome variables
Size of oral lesions
Amount of healing
Amount of pain and burning sensation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201127049502N1
Registration date:2020-12-01, 1399/09/11
Registration timing:prospective
Last update:2020-12-01, 1399/09/11
Update count:0
Registration date
2020-12-01, 1399/09/11
Registrant information
Name
Arezoo Rahimzamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2680 1139
Email address
zamani_arezoo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of a combined mouthwash of triamcinolone acetonide 0.1% and Q10 coenzyme in the treatment of oral lichen planus
Public title
The effect of triamcinolone and Q10 coenzyme in the treatment of oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptomatic oral lichen planus (erosive or atrophic form) who have a sense of burning or pain.
The diagnosis is clinical (Wickham striae or papules) and in cases in which a definitive diagnosis of the lesion is difficult, a histopathological evaluation will be used.
The patient should not have used topical corticosteroid treatments in the last two weeks or systemic corticosteroids in the last month.
The patient should not have used analgesics and anesthetics.
Exclusion criteria:
Patients with lichenoid lesions caused by medication or dental materials
Pregnant or lactating patients
Patients with other lesions such as leukoplakia and systemic lupus in conjunction with lichen planus
History of malignancy
Non-cooperative patients and patients who do not use drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
A simple method of randomization will be done.
In this way, each patient is assigned a number (from 1 to 18), according to the referral time. Patients with odd numbers are then given mouthwash A and patients with even numbers are given mouthwash B. The type of each mouthwash A and B (which is triamcinolone mouthwash and which is triamcinolone and Q10 combination mouthwash) is unknown to the patient and researcher, and only the pharmacist is aware of that. At the end of the study, the type of mouthwashes will be asked for data decode and analysis.
Blinding (investigator's opinion)
Double blinded
Blinding description
Mouthwashes are provided in the same color, smell, and appearance, in bottles of the same shape.
In this study, the researcher and the patient will not know the type of drugs. (double-blind)
Patient examination and evaluation of oral lesions are done by one person before and after the treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-11-02, 1399/08/12
Ethics committee reference number
IR.SBMU.DRC.REC.1399.064
Health conditions studied
1
Description of health condition studied
oral lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
severity and size of the lesions based on REU index
Timepoint
baseline(day0), day15, day30
Method of measurement
Graded tongue blade
2
Description
amount of healing based on Efficacy Index
Timepoint
baseline(day0), day15, day30
Method of measurement
formula
3
Description
severity of burning sensation based on VAS Index
Timepoint
baseline(day0), day15, day30
Method of measurement
Scoring by the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients receive 0.1% triamcinolone mouthwash. mouthwash will be used four times a day in the amount of 15 ml each time (by the measure) and then patients shouldn't eat or drink anything for half an hour. The mouthwash should be gargled in the mouth for two minutes.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, patients receive triamcinolone and coenzyme Q10 combined mouthwash. mouthwash will be used four times a day in the amount of 15 ml each time (by the measure) and then patients shouldn't eat or drink anything for half an hour. The mouthwash should be gargled in the mouth for two minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
school of dentistry, Shahid Beheshti university of Medical Sciences
Full name of responsible person
Arezoo Rahimzamani
Street address
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2311
Fax
+98 21 2240 3194
Email
zamani_arezoo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Tehranchi
Street address
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2311
Fax
+98 21 2240 3194
Email
Denttl@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arezoo Rahimzamani
Position
postgraduate student of oral medicine
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2311
Fax
+98 21 2240 3194
Email
zamani_arezoo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahin Bakhshi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2311
Fax
+98 21 2240 3194
Email
mahinbakhshi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arezoo Rahimzamani
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, Shahid Beheshti University of Medical Sciences, Daneshjou Blvd, Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2680 1139
Fax
Email
zamani_arezoo@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially publishable after Anonymizing patients' identities
When the data will become available and for how long
Data will be available 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
Researchers working in academic and scientific institutions should send an email to the corresponding person and request the data
What processes are involved for a request to access data/document
Researchers working in academic and scientific institutions should send an email to the corresponding person and request the data