A clinical trial to compare the effectiveness of ibuprofen with low intensity pulsed ultrasound in pain reduction after initial archwire placement in orthodontic patient.
To compare the effectiveness of ibuprofen with low intensity pulsed ultrasound in pain reduction after initial archwire placement in orthodontic patient.
Design
In this double-blinded clinical trial with a control group, 60 patients whose undergoing orthodontic treatment will be selected as parallel groups using a table of random numbers.
Settings and conduct
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, the participants and responsible for data collection are unaware the kind type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female with aged range 14-30 years; no history of systemic disease; nonuse of analgesic.
Exclusion criteria: Having drug intolerance; having gastrointestinal disorders.
Intervention groups
Intervention group I will receive pulsed ultrasound waves with 100mW/cm2 and 1MHz frequency for 5 mints around the mouse after initial archwire placement. This process will be repeated every 24 hours for a week in case of pain. Intervention group II will receive 400 mg ibuprofen every 8 hours after initial archwire placement. Control group will receive placebo after initial archwire placement.
Main outcome variables
Evaluation and comparison of the pain rate in chewing, biting, tipping anterior teeth in 2 and 6 hours, as well as 2, 3, and 7 days after the intervention in the three intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190825044606N1
Registration date:2019-09-06, 1398/06/15
Registration timing:prospective
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Zahra Ahmadi Bemrod
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
ahmadiz921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of ibuprofen with low intensity pulsed ultrasound in pain reduction after initial archwire placement in orthodontic patient.
Public title
The effectiveness of low intensity pulsed ultrasound in pain reduction in orthodontic patient.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female with aged range 14-30 years
No history of systemic disease
Nonuse of analgesic
Exclusion criteria:
Having drug intolerance
Having gastrointestinal disorders
Age
From 14 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, randomly base on Randomizer.org website assigned three intervention groups. A code was allocated to each of the participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, the participants and responsible for data collection are unaware the kind type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-05-01, 1398/02/11
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.045
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.5
ICD-10 code description
Fitting and adjustment of ileostomy and other intestinal appliances
Primary outcomes
1
Description
The pain rate in chewing, biting, tipping anterior teeth
Timepoint
2 and 6 hours, as well as 2, 3, and 7 days after the intervention
Method of measurement
Based on Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group I will receive pulsed ultrasound waves with 100mW/cm2 and 1MHz frequency for 5 mints around the mouse after initial archwire placement. This process will be repeated every 24 hours for a week in case of pain.
Category
Treatment - Devices
2
Description
Intervention group: Intervention group II will receive 400 mg ibuprofen every 8 hours after initial archwire placement.
Category
Treatment - Drugs
3
Description
Control group: Control group will receive placebo after initial archwire placement.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Zahra Ahmadi Bemrod
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
zhra.ahmadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Bemrod
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
zhra.ahmadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Bemrod
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
zhra.ahmadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Ahmadi Bemrod
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
zhra.ahmadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Zahra Ahmadi Bemro provides the analysis code to the applicants via email: zhra.ahmadi@yahoo.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.