Protocol summary

Summary
A total of 54 patients (ages, 18-25) participated in this study at the Ahvaz Jundishapur University of Medical Science of Dentistry's Department of Orthodontics, undergoing separator placement were enrolled in this double blind cross over trial study. Subjects randomly assigned to 1 of 2 experimental groups: A; stage 1: 400 mg starch capsule, stage 2: 650 mg acetaminophen and stage 3: 400 mg ibuprofen, B; stage 1: 400 mg starch capsule, stage 2: 400 mg ibuprofen, stage 3: 650 mg acetaminophen. All medication taken orally half hour before separator placement. Also all medications were alike in appearance and were blind to each subjects and clinician. By the end of the 3 months, each subject had received 3 treatment. Each patient's level of discomfort was assessed with a 10-cm visual analogue scale (VAS), before of placement, immediately after placement, at 2, 12 hours and at morning time of 2, 3, 4 and 5 days. The pain evaluations were made during: chewing, biting and at rest. Patients were asked to complete a questionnaire at appropriate intervals during the week after separator placement. Subjects returned to clinic after 1 week for separator removal. Inclusion criteria: 1) no debilitating systemic disease; 2) currently not using analgesics; 3) no periodontal and endodontic problems in the right down quadrants. Exclusion criteria: haven't any conditions from inclusion criteria.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014022516746N1
Registration date: 2014-07-20, 1393/04/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Parisa Kazemi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 939 800 8275
Email address
parisa_kazemi69@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of acetaminophen and ibuprofen before orthodontic treatment in reducing pain-clinical trial
Public title
Comparison of acetaminophen and ibuprofen before orthodontic treatment in reducing pain
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:1) no specific systemic disease; 2) currently not using analgesics; 3) no periodontal and endodontics problems. Exclusion criterion: the lack of any case inclusion criteria.
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Approval date
2013-07-27, 1392/05/05
Ethics committee reference number
ajums.REC.1392.107

Health conditions studied

1

Description of health condition studied
Orthodontic Pain
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care

Primary outcomes

1

Description
The measure of pain
Timepoint
Before of interference, Immediate after interference, 2-3 hours after interference,atthe bed time, at the morning of 2,3,4 and 5 days after interference
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Measure of pain at chewing, dental contact and at rest whit no contact
Timepoint
Before of interference, Immediate after interference, 2-3 hours after interference,atthe bed time, at the morning of 2,3,4 and 5 days after interference
Method of measurement
Questionnaire

Intervention groups

1

Description
Acetaminophen, 650 miligram oral tablet, single dose half hour before of separator placement
Category
Treatment - Drugs

2

Description
Ibuprofen, oral tablet 400 miligram, single dose half hour before separator placement
Category
Treatment - Drugs

3

Description
Placebo, oral capsul 500 miligram of starch, single dose half hour before separator placement
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school, ahvaz jundishapur university of medical science
Full name of responsible person
Mehrnaz Moradinejad
Street address
Orthodontic department, Dental School, Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Golestan, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Parisa Kazemi
Position
General physician
Other areas of specialty/work
Street address
Orthodontic department, Dental School, Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Phone
+98 84 2572 2339
Fax
Email
parisa_kazemi69@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mehrnaz Moradinejad
Position
Assistant professor
Other areas of specialty/work
Street address
Orthodontic department, Dental School, Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Postal code
Phone
+98 61 1391 4860
Fax
Email
moradinejad62@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Parisa Kazemi
Position
General Physician
Other areas of specialty/work
Street address
Orthodontic department, Dental School, Ahvaz Jundishapur University of Medical Sciences, Golestan
City
Khuzestan
Postal code
6967133749
Phone
+98 84 2572 2339
Fax
Email
parisa_kazemi69@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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