This is a randomized placebo controlled clinical trial investigating the effect of hydroxyzine (25 – 50 mg/day) on 30 children and adolescents with bruxism. There are two parallel groups. One group will receive hydroxyzine and the other group will receive placebo. Assessments will be occurred before the intervention and one month after the onset of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110203930N13
Registration date:2012-07-23, 1391/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-23, 1391/05/02
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-10-25, 1390/08/03
Expected recruitment end date
2012-06-23, 1391/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized placebo controlled clinical trial of the effect of hydroxyzine on bruxism in children and adolescents
Public title
The effect of hydroxyzine on bruxism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children with age range of 3 to 17 years from both gender with bruxism.
Exclusion criteria: Concurrent behavior therapy, psychoanalysis, or relaxation therapy for bruxism; taking benzodiazepines.
Age
From 3 years old to 17 years old
Gender
Both
Phase
2
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Chamran street- Hafez hospital
City
Shiraz
Postal code
Approval date
2011-10-24, 1390/08/02
Ethics committee reference number
CT- 90-2796
Health conditions studied
1
Description of health condition studied
Bruxism
ICD-10 code
F45.8
ICD-10 code description
Other somatoform disorders
Primary outcomes
1
Description
Visual Analogue scale
Timepoint
Pre and post intervention
Method of measurement
Parent report
Secondary outcomes
empty
Intervention groups
1
Description
Hydroxizine, 25 – 50 mg/day
Category
Treatment - Drugs
2
Description
Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences
Full name of responsible person
Samanah Zare
Street address
Hafez hospital, Chamran Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Hafez Hospital, Chamran street
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)