Background: Pain relief is important during orthodontic treatment. The aim of this study is to compare the effect of Ketoprofen and Benzocain gums in pain reduction during fixed orthodontic treatment.
Methods: 30 patients with age range of 15-25 years old who had pain in previous sessions, will randomly be divided into 3 groups, each receives one type of experimental gums including ketoprofen, Benzocain and placebo chewing gums. Aftergiving instructions to the patients, they will receive all types of gums frequently, considering the wash out period. They will use the chewing gums immediately after each orthodontic performance and continue them at every 8 hours interval. Patients will record their pain perception at times of 2, 6, 24hours, and 2, 3 and 7 days using 100 scores visual analogue scale. Friedmann and Wilcoxon analysis are used to compare the mean of pain scores among 3 groups to determine which chewing gum in which stage causes the pain relief.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041416466N3
Registration date:2014-06-27, 1393/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
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
Shahid Beheshti Universiy of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of Ketoprofen and Benzocaine chewing gums in reducing orthodontic pain
Public title
Management of orthodontic pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: participants, in good general health without any reported systematic diseases; no concurrent use of analgesics and anti-inflammatory drugs; feel pain more than 50 according to VAS after previous appointment; caries-free dentition with healthy periodontium and without any endodontic problems in the posterior part of the mouth; crowding between 6-8mm and stage of TX in levelling and alignment stage. Patients will be excluded from the study if they used analgesics and anti-inflammatory drugs during the study, did not complete the questionnaire, did not use or improperly used benzocaine or ketoprofen chewing gums.
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
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 Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Chamran Exp.way
City
Tehran
Postal code
19834
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
660
Health conditions studied
1
Description of health condition studied
orthodontic pain
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Primary outcomes
1
Description
pain
Timepoint
2 h, 6h, 24h, day2(10am and 6 pm), day3(10am and 6 pm) and day7(10 am and 6 pm)
Method of measurement
100 scores visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
ketoprofen(Keto) chewing gum was manufatured with 75mg ketoprufen in R& D department of Minoo industrial company under the consultant pharmacologist. The chewing gum consists of gumbase,sorbitol,Xylitol,malnitol,aspartam,A3sulfamK,ocaliptus essence.Ketoprufen was provided from Switzerland.Keto gum will be instructed immediately after each orthodontic intervention(considering wash-out time) for each of the 30 patients and will be continued every 8 hours till day 7.
Category
Treatment - Drugs
2
Description
Benzocain chewing gum (Benzo) chewing gum was manufatured with 20% benzocain in R& D department of Minoo industry company under the consultant pharmacologist. The chewing gum consists ofgumbase,sorbitol,Xylitol,malnitol,aspartam,A3sulfamK,ocaliptus essence.Benzo was provided from Switzerland.Benzo gum will be instructed immediately after each orthodontic intervention for each of the 30 patients ( providing wash-out time) and will be continued every 8 hours till day 7.
Category
Treatment - Drugs
3
Description
Placebo chewing gum chewing gum was manufatured in R& D department of Minoo industry company under the consultant pharmacologist. The chewing gum consists ofgumbase,sorbitol,Xylitol,malnitol,aspartam,A3sulfamK,ocaliptus essence .Placeboo gum will be used immediately after each orthodontic intervention for each of the 30 patients(considering wash-out time) and will be continued every 8 hours till day 7.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic Department of Shahid Beheshti Univercity of Medical Science
Full name of responsible person
Sara Yousefinia
Street address
Chamran exp.way. Daneshjoo blvd.
City
Tehran
2
Recruitment center
Name of recruitment center
Dr. Eslamian orthodontic office
Full name of responsible person
Dr. Ladan Eslamian
Street address
#60, Satari bvd, Africa Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Universiy of Medical Sciences
Full name of responsible person
Dr. Maryam Moezizadeh
Street address
Shahid Beheshti Universiy of Medical Sciences, Dental School
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Universiy 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
Shahid Beheshti Universiy of Medical Sciences
Full name of responsible person
Sara Yousefinia
Position
Postgraduate student of orthodontic department
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Chamran Exp.way
City
Tehran
Postal code
19834
Phone
+98 21 2990 2304
Fax
Email
yousefiniasara@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Universiy of Medical Sciences
Full name of responsible person
Ladan Eslamian
Position
Professor of orthodontic department
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Chamran Exp.way
City
Tehran
Postal code
19834
Phone
+98 21 8878 2440
Fax
Email
leslamian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Universiy of Medical Sciences
Full name of responsible person
Sara yousefinia
Position
Postgraduate student of orthodontic department
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Chamran Exp.way
City
Tehran
Postal code
Phone
+98 21 2209 3720
Fax
Email
yousefiniasara@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)