Comparison of low power Nd-YAG laser, Myrtus communis extract and Triadent ointment in the treatment of patients with minor and Major aphthous ulcers referred to the Tabriz faculty of dentistry
Comparison of low power Nd-YAG laser, Myrtus communis extract and Triadent ointment in the treatment of patients with minor and Major aphthous ulcers referred to the Tabriz faculty of dentistry
Design
controlled clinical trial, with three-parallel groups, triple -blind
Settings and conduct
This study will be conducted in the clinics of the University of Medical Sciences and the dental faculty of Tabriz.
The random assignment sequence will be determined by a person not involved in the study.
Participants/Inclusion and exclusion criteria
patients with minor and Major aphthous ulcers
Being in the first three days of minor and major aphthous ulcers
Not taking minor and major anti-aphthous drugs
Not having systemic diseases with injuries such as minor and major aphthous
Having the necessary cooperation and satisfaction to conduct research
Having systemic diseases such as hormonal disorders, anemia, celiac disease, etc.
smokers
Use of tobacco
Pregnancy and breastfeeding
Intervention groups
In this study, laser (wave length, 1064 nm; power, 60 mW; pulse frequency, 1800 Hz; duration, 80 seconds per treatment; dose, 6.3 J/cm2) is used. The laser is placed at a distance of 1 cm from the surface of the lesion and will be moved in a sweeping manner on the surface of the lesion using the long pulse method. The laser is used once.
In this study, the patient will use the myrtus communis five times a day until one day after the healing of the lesions. Pour 10 drops of myrtus communis on the cotton and place it on the damaged area for 30 seconds.
In this study, Topical intraoral triamcinolone ointment will be used 4 times a day to cover the entire lesion and will continue until the lesion is resolved. duration of drug administration will be based on the instructions of the drug manufacturer.
Main outcome variables
Pain intensity, lesion size, Recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059238N3
Registration date:2024-03-12, 1402/12/22
Registration timing:registered_while_recruiting
Last update:2024-03-12, 1402/12/22
Update count:0
Registration date
2024-03-12, 1402/12/22
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
2023-12-31, 1402/10/10
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of low power Nd-YAG laser, Myrtus communis extract and Triadent ointment in the treatment of patients with minor and Major aphthous ulcers referred to the Tabriz faculty of dentistry
Public title
Comparison of low power Nd-YAG laser, Myrtus communis extract and Triadent ointment in the treatment of patients with minor and Major aphthous ulcers referred to the Tabriz faculty of dentistry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with minor and Major aphthous ulcers
Being in the first three days of minor and major aphthous ulcers
Not taking minor and major anti-aphthous drugs
Not having systemic diseases with injuries such as minor and major aphthous
Having the necessary cooperation and satisfaction to conduct research
Exclusion criteria:
Having systemic diseases such as hormonal disorders, anemia, celiac disease, etc.
smokers
Use of tobacco
Pregnancy and breastfeeding
Age
From 17 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Randomization will be used to randomly select participants. Of course, the patients will be divided into two groups, minor and major, in a simple random manner. Then, each individual group will be assigned to three groups using balanced block randomization. This method of random allocation ensures that the methods of distribution of interventions are balanced.
Method of random assignment of participants
Stratified Randomization will be used to randomly select participants. First, the patients will be randomly assigned to two minor (30 people) and major (30 people) groups, then each group will be divided into three treatment groups (laser-Myrtus communis and routine) will be allocated. The number of blocks in each floor will be 10 and the volume inside each block will be 3 patients. The order of people entering the study is the sequence within the blocks. This arrangement is done by STATA software version 14. This random allocation method ensures that treatment methods are allocated in a completely balanced way; It also ensures that minor and major patients are distributed in exactly the same number in each of the intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person selecting the research subjects, participants, researchers and data analysts will be unaware of the type of intervention received.
Placebo
Not 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 Sciences
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
3335 5965
Approval date
2023-11-20, 1402/08/29
Ethics committee reference number
IR.TBZMED.REC.1402.621
Health conditions studied
1
Description of health condition studied
minor and Major aphthous ulcers
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
severity of pain
Timepoint
Before the start of the intervention and 1, 3 and 7 days after the intervention
Method of measurement
The severity of pain will be evaluated through visual analogue scale (VAS)
2
Description
The size of lesions
Timepoint
Before the start of the intervention and 1, 3 and 7 days after the intervention
Method of measurement
The size of the lesions will be measured by placing a transparent graduated grid on the lesion, determining the border of the lesion and replacing the transparent graduated grid on 1 mm graph paper, which is a reliable method for measuring the size of the lesions.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this study, laser (wave length, 1064 nm; power, 60 mW; pulse frequency, 1800 Hz; duration, 80 seconds per treatment; dose, 6.3 J/cm2) is used. The laser is placed at a distance of 1 cm from the surface of the lesion using the long pulse method and will be moved on the surface of the lesion in a sweeping manner. The laser is used once.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this study, the patient will use myrtus communis five times a day until one day after the lesions heal. Pour 10 drops of myrtus communis on the cotton and place it on the damaged area for 30 seconds.
Category
Treatment - Drugs
3
Description
Intervention group 3: In this study, Trident ointment will be used in a group of patients. Topical intraoral triamcinolone ointment will be used 4 times a day to cover the entire lesion and will continue until the lesion is resolved. It should be noted that the duration of drug administration will be based on the instructions of the drug manufacturer.
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
+98 914 415 3104
Fax
+98 41 3334 6977
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
Shiva Shahir
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
shivashahir1225@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parya Emamverdizadeh
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
Shiva Shahir
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
shivashahir1225@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