The comparison of the effect of 5% naproxen gel and the placebo gel on reduction of fixed orthodontic pain after elastic separator placement; a randomized clinical trial study
(1) Objectives: The study of 5% naproxen gel in fixed orthodontic pain reduction after elastic separator placement (2) Design: Randomized clinical trial, double blind, split mouth, use of placebo gel in control group, pilot and main study, 30 patients (3) Setting and conduct: The aim of doing the pilot study is assessment of durability, adherence, taste, analgesic effect (to determine which of 3 gels containing 1%, 2% and 4% carbomer has the best adherence and drug relief) and the correct way of using gels. Volunteer patients who cooperate in the pilot study would not be involved in the main study. (4) Sample population: Men and female with 14-20 year old of ages that need bilateral elastic separators for molar banding at the beginning of fixed orthodontic treatment and they present pain after separator placement. Patients who do not use gels or do not complete the questionnaire forms will be omitted from the study. (5) Interventions: Each patient will receive one drug containing gel and one placebo gel (the containers are similar and neither the patient nor the Distributor knows the bottles content). Each patient randomly places gel A in one quadrant and the other gel at another quadrant of the jaw. They are instructed by the trained distributer how to use gels every 8 hour up to 3 days after separator placement (first use of the gels will be just after separator placement in the office.) . (6) Main outcome: Pain; patients will represent their pain with Visual Analogue Scale in the questionnaire form at 2 and 6 hours after separator placement (after first use of the gels) and at 10 A.M. and 6 P.M. at days 2, 3 and 7 after separator placement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010716466N4
Registration date:2016-03-07, 1394/12/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-07, 1394/12/17
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
Investigator
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-04-21, 1395/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of 5% naproxen gel and the placebo gel on reduction of fixed orthodontic pain after elastic separator placement; a randomized clinical trial study
Public title
prevention of orthodontic pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Men 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 and clinician needs to place bilateral elastic separators for molar banding and there is no space between the teeth in the jaw.; Patients are without posterior open bite and the first molars should have antagonist teeth in the opposite jaw.; patients present pain after separator placement.
Exclusion criteria: Patients who do not use naproxen gel and placebo gel will be omitted from the study.; patients who do not complete all parts of the questionnaire forms will be omitted from the study.; patients who use other analgesic drugs during the study will be omitted.; removal of any of separators
Age
From 14 years old to 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
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
Postal code
1983969411
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
598
Health conditions studied
1
Description of health condition studied
The effect of 5% naproxen gel on orthodontic pain reduction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain after orthodontic separator placement
Timepoint
2hours after first use, 6 hours after first use, 10A.M and 6 P.M on days 2,3 and 7 after separator placement
Shahid Beheshti University of Medical Science, School of Dentistry, Orthodontic department
Full name of responsible person
Ladan Eslamian
Position
D.M.D. , M.S.
Other areas of specialty/work
Street address
The Orthodontic department, the third floor, School Of Dentistry, Shahid Beheshti University of Medical Science, Evin, Shahid Chamran highway, Tehran, Iran