Assessment of the effect of 5% naproxen patch on post fixed orthodontic pain after elastic separator placement
Design
30 patients who need bilateral elastic separators for molar banding at the beginning of fixed orthodontic treatment and they present pain after separator placement are chosen and randomly divided into two groups of control and intervention.the containers and the color of placebo and naproxen patches are similar and the patient does not know the bottles' content to set the study blind
Settings and conduct
study is done at personal and school related clinic, about orthodontic pain prevention, randomized and single blind. patients, person who delivers patches to patient and statistic analyst are blind by not knowing patches content and their similar appearance.
Each patient randomly places patch A in one quadrant and the other patch at another quadrant of the jaw while does not know the patch's content. They are instructed by the trained distributer how to use patches every 8 hour up to 3 days after separator placement (first use of the patches will be just after separator placement in the dental office.) .
Participants/Inclusion and exclusion criteria
entry conditions: Male and female with 14-20 year old of ages. patients have no pain in teeth and gingiva at the beginning of study. presence of tight contact between first molar with adjacent teeth. the first molars should have antagonist teeth in the opposite jaw. Patients are without posterior open bite. patients present pain after separator placement.
not entry conditions: using naproxen is contraindicated in patients.
Intervention groups
Each patient will receive one drug containing patches and one placebo patches (the containers and the color of the patches are similar and the patient does not know the bottles' content to set the study blind). Each patient randomly places patch A in one quadrant and the other patch at another quadrant of the jaw while does not know the patch's content. They are instructed by the trained distributer how to use patches every 8 hour up to 3 days after separator placement (first use of the patches will be just after separator placement in the dental office.) .
Main outcome variables
degree of Primary Pain after orthodontic separator placement.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140203016466N5
Registration date:2018-01-21, 1396/11/01
Registration timing:registered_while_recruiting
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Ladan Eslamian
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
ladan.eslamian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,shahid beheshti University of Medical Sciences
researchers:
dr. Ladan Eslamian
dr. Nazila Akbarianrad
dr. seyed alireza mortazavi
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of 5% naproxen patch and the placebo patch on reduction of fixed orthodontic pain after elastic separator placement
Public title
prevention of orthodontic pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female with 14-20 year old of ages.
patients have no pain in teeth and gingiva at the beginning of study.
presence of tight contact between first molar with adjacent teeth.
the first molars should have antagonist teeth in the opposite jaw.
Patients are without posterior open bite.
patients present pain after separator placement.
Exclusion criteria:
using naproxen is contraindicated in patients.
Age
From 14 years old to 20 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
buccal gingiva of right and left first molar
Randomization (investigator's opinion)
Randomized
Randomization description
randomization was done in common method,personal and with quins.
Blinding (investigator's opinion)
Single blinded
Blinding description
the containers and the color of the patches are similar and both the patient and the person who delivers the patches to patients and gets the questionnaires do not know the bottles' content to set the study blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science, School Of Dentistry
Street address
The Research center, the forth floor, School Of Dentistry, Shahid Beheshti University of Medical Science, Evin, Shahid Chamran highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1983969411
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.115
Health conditions studied
1
Description of health condition studied
pain after orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
degree of Primary Pain after orthodontic separator placement
Timepoint
2hours , 6 hours and 24 hours, 10A.M and 6 P.M on days 2,3 and 7 after separator placement
the research center, School Of medicine, Shahid Beheshti University of Medical Science, Evin, Shahid Chamran highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti University of Medical Sciences
Proportion provided by this source
20
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
2
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science, School of Dentistry, Orthodontic department
Full name of responsible person
D.D.S., M.S. Ladan Eslamian
Street address
The Orthodontic department, the third floor, School Of Dentistry, Shahid Beheshti University of Medical Science, Evin, Shahid Chamran highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2304
Email
ladan.eslamian@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science, School of Dentistry, Orthodontic department
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Nazila Akbarianrad
Position
Doctor of Dental surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No4, Sherafat alley, 11th street, Asad abadi street , Tehran
City
tehran
Province
Tehran
Postal code
1433763648
Phone
+98 21 8870 6783
Fax
Email
rad.nazi@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ladan Eslamian
Position
Doctor of Medicine in Dentistry; orthonotist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
The Orthodontic department, the third floor, School Of Dentistry, Shahid Beheshti University of Medical Science, Evin, Shahid Chamran highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2304
Fax
Email
ladan.eslamian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazila Akbarianrad
Position
Doctor of Dental Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no4, Sherafat alley, 11th street, Asad Abadi street , Tehran
City
tehran
Province
Tehran
Postal code
1433763648
Phone
+98 21 8870 6783
Fax
Email
rad.nazi@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available