A comparative study of pain-relieved effect of mucosal prilocaine patches and usage of acetaminophen on elastomeric separator in orthodontic patients: a randomized clinical trial
A comparative study of pain-relieved effect of mucosal prilocaine patches and usage of acetaminophen on elastomeric separator in orthodontic patients
Design
This study is a randomized clinical trial with a parallel design and a control group. This non-blinded study will be conducted on 60 eligible patients. A random block is used for randomization and the participants are assigned to three groups (intervention and control).
Settings and conduct
This study, which will be conducted in the Faculty of Dentistry of Kermanshah University of Medical Sciences, is not blinded. In this study, the mesial and distal elastomeric spacers of the mandibular first molars will be placed
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 14 and 25 years; The presence of first molar, second molar, and second premolar teeth of the lower jaw with strong interproximal contacts; The presence of moderate crowding in the arch of the lower jaw (high irregularity index of 2)
Exclusion criteria:Pregnancy; History of liver or kidney disease; History of allergy to local anesthetics; History of methemoglobinemia
Intervention groups
In the first intervention group, mucosa pieces will be randomly placed in the buccal region of the first molars of the lower jaw on both sides, and prilocaine mucosa adhesive will be used.
In the second intervention group, mucosal pieces will be randomly placed in the buccal area of the first molars of the lower jaw on both sides and acetaminophen will be used.
In the control group, no intervention is performed.
Main outcome variables
intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N214
Registration date:2024-03-08, 1402/12/18
Registration timing:prospective
Last update:2024-03-08, 1402/12/18
Update count:0
Registration date
2024-03-08, 1402/12/18
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-18, 1402/12/28
Expected recruitment end date
2024-06-17, 1403/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of pain-relieved effect of mucosal prilocaine patches and usage of acetaminophen on elastomeric separator in orthodontic patients: a randomized clinical trial
Public title
A comparative study of pain-relieved effect of mucosal prilocaine patches and usage of acetaminophen on elastomeric separator in orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 14 and 25 years
The presence of first molar, second molar and second premolar teeth of the lower jaw with strong interproximal contacts
The presence of moderate crowding in the arch of the lower jaw (high irregularity index of 2)
Exclusion criteria:
pregnancy
History of liver or kidney disease
History of allergy to local anesthetics
History of methaemoglobinemia
Chronic use of NSAIDs, sedatives, or other pain relievers
Age
From 14 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.KUMS.REC.1402.552
Health conditions studied
1
Description of health condition studied
Orthodontic Pain
ICD-10 code
Z51.8
ICD-10 code description
Encounter for other specified aftercare
Primary outcomes
1
Description
intensity of pain
Timepoint
2, 6, 12, and 24 hours after the intervention, bedtime, 2, 3, and 7 days after the intervention
Method of measurement
Based on Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, mucosa pieces will be randomly placed in the buccal region of the first molars of the lower jaw on both sides, and prilocaine mucosa adhesive will be used.
Category
Treatment - Other
2
Description
In the second intervention group, mucosal pieces will be randomly placed in the buccal area of the first molars of the lower jaw on both sides and acetaminophen will be used.
Category
Treatment - Other
3
Description
In the control group, no intervention is performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Kermanshah University of Medical Sciences
Full name of responsible person
Mahya Tajjik
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
mahyatajjik99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mahya Tajjik
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
mahyatajjik99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Azizi
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
3889azizi3889@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. fatemeh Azizi
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
3889azizi3889@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD