Investigating the effect of melatonin combined with betamethasone mouthwash compared to betamethasone mouthwash alone in the treatment of ulcerative oral lichen planus
Investigating the effect of melatonin combined with betamethasone mouthwash compared to betamethasone mouthwash alone in the treatment of ulcerative oral lichen planus
Design
controlled clinical trial, phase 3, with two-parallel groups, triple -blind
Settings and conduct
This study will be conducted in Tabriz Dental Faculty. The random assignment sequence will be determined by a person not involved in the study using G-Power software. To hide the allocation of drugs, they will be placed in opaque envelopes, numbered consecutively. Eligible people will be placed in two intervention and control groups using the random block method with a block size of 4 and with a 1:1 allocation sequence.
Participants/Inclusion and exclusion criteria
Entry criteria include: diagnosis of oral lichen planus using clinical criteria and histopathology confirmation, age range 18 to 70 years; Exclusion criteria include: pregnancy and breastfeeding, use of immunosuppressive drugs
Intervention groups
Intervention group: Intervention group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time, and 5 mg melatonin tablet 1 tablet two hours before bedtime for 9 weeks.
Control group: Control group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time and a placebo containing (starch and magnesium stearate) 1 piece a day two hours before going to sleep will be used for 9 weeks
Main outcome variables
Pain intensity, lesion size, Thongprasom scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059238N2
Registration date:2023-12-23, 1402/10/02
Registration timing:registered_while_recruiting
Last update:2023-12-23, 1402/10/02
Update count:0
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
Parya Emamverdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
emamverdizdeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-11, 1402/09/20
Expected recruitment end date
2024-05-30, 1403/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of melatonin combined with betamethasone mouthwash compared to betamethasone mouthwash alone in the treatment of ulcerative oral lichen planus
Public title
Investigating the effect of melatonin combined with betamethasone mouthwash compared to betamethasone mouthwash alone in the treatment of ulcerative oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of ulcerative oral lichen planus based on clinical findings: white and red components with different designs, presence of reticular or papular tissue with erogenous lesions and histopathological criteria: 1) hyperparakeratosis or hyperorthokeratosis areas, often with thickening of the granular cell layer and a saw-tooth appearance in Rat pegs 2) Condensed degeneration or necrosis in the basal cell layer 3) An eosinophilic band that may be seen just below the basement membrane and contains fibrin covering the lamina propria. 4) Dense subepithelial band-like infiltration of lymphocytes and macrophages 5- Presence Ulcer or fibrinopurulent membrane
Patients with complete records including demographic and clinical information
Patients without underlying disease
People who have the ability to give informed consent and do not need a legal representative.
Exclusion criteria:
pregnant women
People with underlying disease
Any treatment that has been done for these injuries
Use of immunosuppressive drugs
Incomplete file
The patient's unwillingness to participate in the research
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be placed in two intervention and control groups using a random block method with a block size of 4 and with a 1:1 allocation sequence. The allocation sequence will be determined by a person not involved in the study using G-Power software, placed in consecutively numbered opaque envelopes to conceal drug or placebo allocation, and prepared according to the allocation sequence. It will be done by a person not involved in the research from number 1 to 32.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Medicines will be packed in two separate envelopes in a completely similar way in terms of shape and color. The person selecting the research subjects, participants, researchers and data analysts will be unaware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Science
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.TBZMED.REC.1402.564
Health conditions studied
1
Description of health condition studied
Oral lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
severity of pain
Timepoint
Before starting the intervention, 4 and 9 weeks after the intervention
Method of measurement
The severity of pain will be evaluated through visual analogue scale (VAS)
2
Description
The size of the lesions
Timepoint
Before starting the intervention, 4 and 9 weeks after the intervention
Method of measurement
The size of the lesions will be measured with the help of gauze paper.
3
Description
Appearance of lesions
Timepoint
Before starting the intervention, 4 and 9 weeks after the intervention
Method of measurement
The appearance of lesions will be measured by Thongprasom scale and includes 6 grades: zero = perfectly healthy, 1 = mild white lines without inflammatory regions, 2 = white lines with atrophic regions smaller than 1 cm2, 3 = white lines with atrophic regions larger than 1 cm2, 4 = white lines accompanied with erosive regions less than 1 cm2, 5 = white lines with erosive areas larger than 1 cm2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time, and 5 mg melatonin tablet 1 tablet two hours before bedtime for 9 weeks.
Category
Treatment - Drugs
2
Description
Control group: Control group: Mg aluminum mouthwash and betamethasone 3 times, 5 cc each time and a placebo containing (starch and magnesium stearate) 1 piece a day two hours before going to sleep will be used for 9 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty at Tabriz university of medical sciences
Full name of responsible person
Parya Emamverdizadeh
Street address
Tabriz University of Medical Sciences, Dental faculty, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
emamverdizadeh@bzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Research department, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
dabirkhanecent@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
Yousef Navidpour
Position
Dental Student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Dental Faculty, Golgasht Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Yousefnavidpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parya Amvardizadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Dental faculty, Golgasht Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
emamverdizadeh@bzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Yousefnavidpour
Position
Dental Student
Latest degree
Bachelor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Dental Faculty, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Yousefnavidpour@gmail.com
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