To compare the effectiveness of ibuprofen with curcumin in pain reduction after initial archwire placement in orthodontic patient
Design
Totally, 60 patients whose undergoing fixed orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using simple sampling methods.
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 single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
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 special medical condition; having drug intolerance; having gastrointestinal disorders.
Intervention groups
Intervention group I will receive 400 mg ibuprofen every 8 hours after initial archwire placement. Intervention group II will receive 80 g curcumin tablets every 8 hours after initial archwire placement. The 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, and put posterior teeth on each other in 2 and 6 hours, as well as 2 days after the intervention in the three intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200609047705N1
Registration date:2020-06-10, 1399/03/21
Registration timing:prospective
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Homan Shafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
shafaeeh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
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 curcumin in pain reduction after initial archwire placement in orthodontic patient
Public title
The effectiveness of curcumin 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 a special medical condition
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
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into three groups of 20 patients with blocks of 2, 4, and 6 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Accordingly, the participants were given codes and assigned to the three intervention and control groups.
Blinding (investigator's opinion)
Single 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 single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
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
2019-10-02, 1398/07/10
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.074
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
Timepoint
2, 6 hours, and 2 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
The pain rate in biting
Timepoint
2, 6 hours, and 2 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)
3
Description
The pain rate in tipping anterior teeth
Timepoint
2, 6 hours, and 2 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)
4
Description
The pain rate in put posterior teeth on each other
Timepoint
2, 6 hours, and 2 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group I will receive 400 mg ibuprofen every 8 hours after initial archwire placement.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group II will receive 80 g curcumin tablets every 8 hours after initial archwire placement.
Category
Treatment - Drugs
3
Description
Control group: Control group will receive placebo after initial archwire placement.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Mohammad Parsa Ghiasi
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
Parsa.ghiasi73@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
9138813944
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
Mohammad Parsa Ghiasi
Position
Student
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
9138813944
Phone
+98 51 3883 2300
Email
Parsa.ghiasi73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Parsa Ghiasi
Position
Student
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
9138813944
Phone
+98 51 3883 2300
Email
Parsa.ghiasi73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Parsa Ghiasi
Position
Student
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
9138813944
Phone
+98 51 3883 2300
Email
Parsa.ghiasi73@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can 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 at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Mohammad Parsa Ghiasi provides the data analysis to the applicants via email: Parsa.ghiasi73@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.