Efficacy of Low-Intensity Pulsed Ultrasound for Orthodontic Pain Control
Design
Randomised trial with control and experiential parallel group,
double blinded (patient and outcome assessment)
Settings and conduct
22 patients presenting to the Orthodontics Department of Shahid Beheshti School of Dentistry and two private clinics in Tehran. Separators were placed at the mesial and distal of mandibular right and left first molars using separating pliers. low-intensity pulsed ultrasound (LIPUS) was used at one side for 7 minutes and the same device with 0-degree intensity was used as sham for the other side on the facial skin.
In this study, the patient and outcome assessment were blinded to the use of on or off the device.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Absence of periodontal or endodontic problems or active caries, no pain at the onset of study, absence of spacing and presence of tight contacts between the permanent first molar and adjacent teeth, no intake of systemic analgesics, presence of antagonistic tooth, absence of posterior open bite, willingness for participation in the study and patient expressing pain following placement of orthodontic separators.
exclusion criteria :
detachment of a separator, not filling out the questionnaire and use of analgesics during the study period.
Intervention groups
Mandibular right and left First molar in 22 patients
Main outcome variables
Orthodontic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160626028640N2
Registration date:2018-02-10, 1396/11/21
Registration timing:retrospective
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
mohammadreza badiee
Name of organization / entity
Dentofacial Deformities Research Center,
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 7752
Email address
mohammadreza.badiee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Low-Intensity Pulsed Ultrasound for Orthodontic Pain control
Public title
Efficacy of Low-Intensity Pulsed Ultrasound for Orthodontic Pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of periodontal or endodontic problems or active caries,
no pain at the onset of study,
absence of spacing and presence of tight contacts between the permanent first molar and adjacent teeth
no intake of systemic analgesics,
presence of antagonistic tooth,
absence of posterior open bite,
patient expressing pain following placement of orthodontic separators.
Exclusion criteria:
detachment of a separator
not filling out the questionnaire
use of analgesics during the study period.
Age
From 19 years old to 32 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
2
Separators were placed at the mesial and distal of mandibular right and left first molars using separating pliers. low-intensity pulsed ultrasound (LIPUS) was used at one side for 7 minutes and the same device with 0-degree intensity was used as sham for the other side on the facial skin.
Actual sample size reached:
22
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and evaluators are unaware about the consequences of using an ultrasound device on or off.
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 Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo BLV, Chamran Highway, Evin
City
Tehran
Province
Tehran
Postal code
19839
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
IR.SBMU.RIDS.REC.1394.169
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Orthodontic Pain based on VAS
Timepoint
Patients were requested to record their level of pain at one, six and 24 hours and also on days two to seven after placement of separators
Method of measurement
visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pain evaluation after placement of seperator in mesial and distal of mandibular first molar and use of low-intensity pulsed ultrasound (LIPUS) for 7 minutes with degree 100 intensity
Category
Treatment - Devices
2
Description
Control group: Pain evaluation after placement of seperator in mesial and distal of mandibular first molar and use of low-intensity pulsed ultrasound (LIPUS) for 7 minutes with 0-degree intensity
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Badiee
Street address
Shahid Beheshti Dental School, Daneshjoo BLV, Chamran Highway, Evin
City
Tehran
Province
Tehran
Postal code
19839
Phone
+98 21 2242 8638
Email
mohammadreza.badiee@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Tehranchi
Street address
Dental school, Daneshjoo BLV, Chamran highway, Evin
City
Tehran
Province
Tehran
Postal code
19839
Phone
+98 21 2242 7752
Email
azitatehranchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?