Comparison of the effectiveness of mouthwash containing betamethasone with mouthwash containing dexamethasone in reducing the pain level of patients with symptomatic oral lichen planus
Comparison of the effectiveness of betamethasone-containing and dexamethasone-containing mouthwash in reducing pain in symptomatic oral lichen planus
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 34 patients. The lottery method will be used for randomization.
Settings and conduct
This study will be performed in the Department of Oral and Maxillofacial Diseases of Tabriz Dental School. Patients will be randomly divided into two groups A and B. The total number of patients is 34, which will be placed in each group of 17. Double-blind correction will be performed in such a way that the patient and the researcher will not be aware of the contents of the bottles. The A-labeled bottle will contain 15 cc of betamethasone in combination with 200 cc of AlMg gastric syrup and the B bottle will contain 15 cc of dexamethasone in combination with 200 cc of AlMg gastric syrup. To measure the extent of changes in the severity of symptoms, the Visual Analog Scale (VAS) will be used and the amount of VAS on the first day of referral will be compared with 6 weeks later.
Participants/Inclusion and exclusion criteria
Admission requirements: Patients with symptomatic oral lichen planus; Conditions of absence: Patients with oral lichen planus for whom corticosteroids are contraindicated.
Intervention groups
In this study, patients in one group received a mouthwash containing betamethasone for the other group, given a mouthwash containing dexamethasone and the effectiveness of the two will be compared.
Main outcome variables
Change in pain values according to VAS criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220509054789N1
Registration date:2022-05-17, 1401/02/27
Registration timing:prospective
Last update:2022-05-17, 1401/02/27
Update count:0
Registration date
2022-05-17, 1401/02/27
Registrant information
Name
Sahar Khademnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 6097
Email address
khademnezhad@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of mouthwash containing betamethasone with mouthwash containing dexamethasone in reducing the pain level of patients with symptomatic oral lichen planus
Public title
Comparison of the effectiveness of mouthwash containing betamethasone with dexamethasone in reducing the pain level of oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptomatic OLP who have not yet received treatment.
Confirmation of OLP diagnosis by histological sampling
Age over 18 years
Exclusion criteria:
Pregnancy
Having uncontrolled diabetes
Getting a stomach ulcer
Having a systemic disease for which corticosteroids are contraindicated.
Observation of dysplasia in the view of histopathology
Get other treatments for OLP
Infection of skin lesions
Taking psychiatric drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups A and B. Sealed envelopes will be used for this purpose. They will be sealed by writing group A or B inside the envelopes. The envelopes are then mixed and the first envelope is removed at each patient's visit and assigned to the group inside the envelope. The examining dentist does not know which group A and B each belong to.
Blinding (investigator's opinion)
Double blinded
Blinding description
The double-blind method will be implemented, In this way, the patient, researcher and data analyzer will not be aware of the contents of the bottles. Sampling and assignment of individuals to each group will remain secret for the patient and the researcher until the end of the study. Bottles with similar appearance will be divided into two categories.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics comittees of Tabriz university of medical sciences
Street address
Research Vice- Chancellor, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz, Iran, ,
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.TBZMED.REC.1401.081
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
Pain
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Use the Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15 cc long-acting betamethasone (Kimia Drug Co.) in combination with 200 cc of AlMg stomach syrup, 3 times a day, 5 cc each time for 30 seconds, for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: 15 cc long-acting Dexamethasone (Kimia Drug Co.) in combination with 200 cc of AlMg stomach syrup, 3 times a day, 5 cc each time for 30 seconds, for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty of Tabriz
Full name of responsible person
Sahar Khademnezhad
Street address
Tabriz University of Medical Sciences/ Tabriz University, Golgasht Avenue, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5966
Email
info@dentistryfac.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Khademnezhad
Street address
ّFaculty of dentistry, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3177 2023
Email
info@dentistryfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Khademnezhad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
ّFaculty of dentistry, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3177 2023
Email
skhdent@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Khademnezhad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
ّFaculty of dentistry, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3333 6097
Fax
Email
khademnezhad@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Khademnezhad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
ّFaculty of dentistry, Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3333 6097
Fax
Email
khademnezhad@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available