Determination of pain intensity and number of wounds in orthodontic patients who use wax and placebo
Determination of pain intensity and number of wounds in orthodontic patients who use wax and probiotics
Comparison of pain intensity and number of wounds in orthodontic patients who use wax and placebo with patients who use wax and peiobiotic
Design
The clinical trial has a control group with a parallel group of a blinded strain, on 30 patients. A table of random numbers in sealed envelopes will be used for randomization. Patients will be divided into intervention and control groups.
Settings and conduct
36 patients over 12 years of age and candidates for fixed orthotic treatment are divided into two control groups and the target group. Random numbers table in sealed envelopes will be used for randomization. Patients will be divided into intervention and control groups.
The control group receives orthodontic waxes and placebo and they are told that if the components of the orthodontic device cause an ulcer in the oral tissue, they should soften the wax in their hand and place it on the area that caused the ulcer. and take the placebo for 4 weeks by placing the lozenge in the mouth and giving it enough time to completely dissolve in the mouth. The target group also receives the same orthodontic waxes and related explanations as the control group. In addition to bromide, they will receive lactogam probiotic lozenges from the beginning of the treatment. If the patient returns earlier than 28 days due to tissue irritation, he will be excluded from the study. They are witnesses.
Participants/Inclusion and exclusion criteria
The upper age is 12 years
Have good hygiene
Intervention groups
Patients consuming probiotics
Main outcome variables
Pain based on visual analogue scale
number of wounds
Bleeding wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230208057356N1
Registration date:2023-03-29, 1402/01/09
Registration timing:registered_while_recruiting
Last update:2023-03-29, 1402/01/09
Update count:0
Registration date
2023-03-29, 1402/01/09
Registrant information
Name
Tannaz Abdollahzadeh baghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 8046
Email address
abdollahzadeht@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-28, 1401/12/09
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using probiotics along with orthodontic wax on the pain and ulcers relief in patients undergoing fixed orthodontic treatment
Public title
The effect of using probiotics along with orthodontic wax on the pain and ulcers relief in patients undergoing fixed orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The upper age is 12 years
A candidate to receive permanent orthodontic treatment.
Have good hygiene
Exclusion criteria:
The woman should not be pregnant or lactating
Do not have a specific (systemic) disease
To consume tobacco, alcohol and any addictive substances
Do not have periodontal disease
Do not have a history of hypersensitivity or sensitivity to the tested substance
Severely buccal or labial teeth that are prone to severe ulceration are not treated during the first sessions
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization based on sex.
People are randomly placed in one of the two study groups with the help of a random number table and receive the intervention related to the same group. In order to hide the random allocation, the method of sealed opaque envelopes with a random sequence (envelopes opaque, sealed, numbered sequentially) will be used. In this method, each of the generated random sequences is recorded on a card and The cards are placed in the letter envelopes in order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the person examining the teeth will be blinded and will examine the teeth before and after the intervention without knowing which group the patient was in.
The patient or his legal guardian will not be blinded because the type of intervention is visible and recognizable. Of course, patients will be assigned to random groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.TBZMED.REC.1401.589
Health conditions studied
1
Description of health condition studied
بیمار دارای مال اوکلوژن
ICD-10 code
M26.4
ICD-10 code description
Malocclusion, unspecified
Primary outcomes
1
Description
pain
Timepoint
30 days after gluing the brackets
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These patients receive orthodontic waxes and it is explained to them that if the components of the orthodontic device cause a wound in the oral tissue, they should soften the wax in their hand and place it on the part that caused the wound and until the wound heals. Renew the wax. In addition to wax, this group will receive Lactogam probiotic lozenges from the beginning of the treatment, and the method of using these lozenges will be once a day for 4 weeks after using a toothbrush and dental floss. The lozenge is placed in the mouth and given enough time to dissolve completely in the mouth. Patients will be taught to stop taking probiotics if they develop symptoms of allergy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشگاه علوم پزشکی تبریز
Full name of responsible person
Pzrviz Shahabi
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
51656665931
Phone
+98 41 4333 8042
Email
research-vice@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
پرویز شهابی
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor, Research and Technology Vice-Chancellor
City
Tbriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 4333 8042
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.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
Mahsa Jafari Tayebpur
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 4333 8042
Email
mahsa.jafariii97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tanaz Abdullahzadeh Baghai
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 4333 8042
Email
abdollahzadeht@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehsa Jafari Tayyebpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor, Research and Technology Vice-Chancellor
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 4333 8042
Email
mahsa.jafariii97@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be reported in the form of articles and student theses, and raw data can be provided upon request.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions, doctors and dentists.
Under which criteria data/document could be used
The use of data for further research or therapeutic measures is permitted
From where data/document is obtainable
Katayon Katbi 00984133355965 Tabriz Dental University, Department of Oral Diseases.
Katebi@tbzmed.ac.ir
What processes are involved for a request to access data/document
The applicant sends request via email and the information and data are sent to email.