The aim of the present study is to assess effectiveness of benzocaine-contained toothpaste in decreasing pain caused by fixed orthodontics. Study population consists of all patients undergoing orthodontic treatment and experience pain after appointment. By considering 20% lost to follow up, sample size was calculated to be 33. Inclusion criteria include, fixed orthodontic patients in initial appointments who report pain experience after previous appointment. Presence of liver and kidney problems and also allergy to local anesthesia lead to exclusion of samples. The study is designed to be cross-over, i.e patients would receive benzocaine toothpaste, placebo toothpaste or only questionnaire in three sequential appointments. Patients were instructed to use toothpaste for 3 days and mark their pain in a zero to 100 scale in predetermined intervals. Primary outcome is pain reported by patient. Between each appointment there is 4 weeks interval.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010120523N1
Registration date:2015-04-16, 1394/01/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-16, 1394/01/27
Registrant information
Name
Sepideh Soheilifar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 2508
Email address
sepidehsoheilifar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental research center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-09-20, 1394/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of benzocaine-contained tooth paste on relieving orthodontic pain
Public title
the effect of benzocaine-contained tooth paste in decreasing fixed orthodontic pain
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: patients in leveling and alignment stage who report pain in previous visit; presence of 6-8 crowding; patient informed consent
exclusion criteria:history of liver, kidney or allergy to local anesthesia; history of chronic pain and continuous administration of anti pain drugs; presence of dental or mucosal pain; presence of mucosal wound
Age
From 15 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
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
Dental Research Center, Research Institute of Dental Sciences of Shahid Beheshti University of Medic
Street address
Dental Faculty, Shahid Beheshti University of Medical Sciences, Daneshjou Boulvard, Evin
City
Tehran
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
21
Health conditions studied
1
Description of health condition studied
pain percieved after fixed orthodontic appointment
ICD-10 code
Y70-Y82
ICD-10 code description
Medical devices associated with adverse incidents in diagnostic and therapeutic use
Primary outcomes
1
Description
pain
Timepoint
2 hours and 6 hours after appointment, at the night of appointment, at 10am and 6pm on second and third day and on 10am on 7th day
Method of measurement
visual analogue scale (VAS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
benzocaine group: 5% benzocaine is added to a commercially available toothpaste, along with 0.075% Aspartam in order to mask benzocaine taste. each patient is given a toothpaste and asked to brush his/her teeth immediately after appointment, after breakfast and lunch and before sleep for 3 days. meanwhile, they are asked to mark their pain in a 0-100 scale, 2hours and 6hours after appointment, the same night before sleep, 10am and 6pm in second and third day and 10am at 7th day.
Category
Treatment - Drugs
2
Description
placebo group: a commercially available toothpaste is filled in identical tube as benzocaine tooth paste and is given to patients. patients are asked to use this toothpaste immediately after appointment, after breakfast and lunch and before sleep for 3 days. they are asked to mark their pain in a 0-100 scale 2 hours and 6 hours after appointment, at the same night before sleep, at 10am and 6pm on second and third day and at 10am on 7th day.
Category
Placebo
3
Description
control group: the patients are given a questionnaire with a 0-100 scale to mark their pain 2hours and 6 hours after appointment, at the same night before sleep, at 10am and 6pm on second and third day, at 10am on 7th day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
orthodontic department at dental faculty, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Research Center, Research Institute of Dental Sciences of Shahid Beheshti University of Medic
Full name of responsible person
Dr Asghar Ebadifar
Street address
Dental Faculty, Shahid Beheshti University of Medical Sciences, Daneshjou Boulvard, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Center, Research Institute of Dental Sciences of Shahid Beheshti University of Medic
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 University of Medical Sciences
Full name of responsible person
Sepideh Soheilifar
Position
postgraduate student (resident) of orthodontic department
Other areas of specialty/work
Street address
Orthodontic department, third floor, dental faculty, Shahid Beheshti University, Evin
City
Tehran
Postal code
Phone
+98 21 2241 3897
Fax
Email
se.soheilifar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Orthodontic department Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ladan Eslamian
Position
Professor at orthodontic department
Other areas of specialty/work
Street address
orthodontic department, Dental Faculty, Shahid Beheshti Univeristy, Daneshjou Boulvard, Evin
City
Tehran
Postal code
Phone
+98 21 2241 3897
Fax
Email
leslamian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Sepideh Soheilifar
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)