Protocol summary

Summary
In this double blind randomized clinical trial study effect of meloxicam, ibuprofen and acetaminophen on post separator pain will be evaluated and compared. 321 patients who need fixed orthodontic therapy and are older than 15 years old will be selected. All participants must have the following criteria: not currently using antibiotics, analgesics; anti – inflammatory, anti-coagulative, diuretics, oral anti diabetics, lithium, cyclosporine and methotrexate; no need for antibiotic prophylaxis; no chronic systemic disease or clotting disorders; not reporting contraindication for NSAIDs; not pregnant or nursing. Patient who use any other analgesic during the period of study will be excluded. The patients will be divided to three groups: group A (650 mg acetaminophen), group B (400 mg ibuprofen) and group C (7.5 mg meloxicam). All patients will be given only one tablet, 1 hour before separator placement. A visual analogue scale (VAS) will be used to determine the degree of the pain and discomfort at the following intervals: Immediately after separator placement, 2 hours post treatment, 6 hours post treatment, 24 hours post treatment, and 48 hours after separator placement. Patients will be instructed to mark the degree of the pain with a short vertical line on the VAS during three oral situations including rest, fitting posterior teeth, and chewing, and return the questionnaire in the next visit (a week later).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015041821828N1
Registration date: 2015-06-05, 1394/03/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-05, 1394/03/15
Registrant information
Name
Neda Babanouri
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 713230541019
Email address
stud3961854483@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2015-02-11, 1393/11/22
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of preemptive acetaminophen, ibuprofen, and meloxicam on pain after separator placement: a randomized clinical trial
Public title
Effect of meloxicam on orthodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: not currently using antibiotics; analgesics, anti – inflammatory, anti-coagulative, diuretics, oral anti diabetics, lithium, cyclosporine and methotrexate; no need for antibiotic prophylaxis; no chronic systemic disease or clotting disorders; not reporting contraindication for NSAIDs; not pregnant or nursing exclusion criteria: use any analgesic during the study time
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 321
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
central building of Shiraz University of Medical Science, Zand avenue, Shiraz, Iran
City
Shiraz
Postal code
71348-14336
Approval date
2010-11-13, 1389/08/22
Ethics committee reference number
CT-P-8928-2168

Health conditions studied

1

Description of health condition studied
post separator placement pain
ICD-10 code
R52.0
ICD-10 code description
acute pain

Primary outcomes

1

Description
post separator pain
Timepoint
immediately, 2 hour, 6 hour, 24 hour and 48 hour after separator placement
Method of measurement
visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
ibuprofen 400 mg orally one hour before separator placement
Category
Treatment - Drugs

2

Description
acetaminophen 650 mg orally one hour before separator placement
Category
Treatment - Drugs

3

Description
meloxicam 7.5 mg orally one hour before separator placement
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontic Clinic of Dental School at Shiraz University of Medical Sciences, Iran
Full name of responsible person
Street address
ِDental school, Ghasr-al-dasht avenue, Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of MedicalSscience
Full name of responsible person
Dr. Basir Hashemi ,Vice President of research
Street address
cental building of Shiraz university of Medical Science, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of MedicalSscience
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
Shiraz University of Medical Science
Full name of responsible person
Neda Babanouri
Position
post graduated student of orthodontics
Other areas of specialty/work
Street address
Central building of Shiraz university of Medical Science ,Zand Avenue, Shiraz, Iran
City
Shiraz
Postal code
71348-14336
Phone
+98 713230541019
Fax
Email
stud 3961854483@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Neda Babanouri
Position
post graduated student of orthodonics
Other areas of specialty/work
Street address
central building of Shiraz university of Medical Science, zand avenue, Shiraz, Iran
City
Shiraz
Postal code
71348-14336
Phone
+98 713230541019
Fax
+98 71 3212 2430
Email
stud3961854483@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Neda Babanouri
Position
post graduated student of orthodontics
Other areas of specialty/work
Street address
central building of shiraz university of medical science, Zand avenue, Shiraz ,Iran
City
Shiraz
Postal code
Phone
00
Fax
Email
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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