The aim of this study was to evaluate the effect of oral Calcium on reducing orthodontic pain and to compare this effect with Acetaminophen. In this clinical trial study, 40 female patients (14-19 years old) undergoing fixed orthodontic treatment, had passed at least two visits, and their pain intensity was 40-100 mm (VAS) were selected and randomly assigned to 2 groups. Psychotic status of these groups was measured with HADS (Hospital Anxiety & Depression Scale). Pain intensity before taking drug was measured with VAS (visual analogue scale). The first group took 60 calcium fort tablets (one tablet daily) and the second group took 60 Acetaminophen 325mg tablets (one tablet daily). Pain intensity was measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806282481N1
Registration date:2010-02-19, 1388/11/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-19, 1388/11/30
Registrant information
Name
Soghra Yassaei
Name of organization / entity
Dental School
Country
Iran (Islamic Republic of)
Phone
+98 35 1823 8087
Email address
syassaei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2009-05-15, 1388/02/25
Expected recruitment end date
2009-09-20, 1388/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of oral calcium on reducing orthodontic pain.
Public title
The evaluation of effect of oral calcium on reducing orthodontic pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female patients (14-19 years old) undergoing fixed orthodontic treatment. Having visited two times, pain intensity 40-100mm (VAS)
Exclusion criteria: calcium intake in past, kidney stones, ventricular fibrillation, hypoparathyroidism
Age
From 14 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research
Street address
Shahid Sadoughi University of Medical sciences and Health Services
City
Yazd
Postal code
Approval date
2009-04-11, 1388/01/22
Ethics committee reference number
4564/1/17/ب
Health conditions studied
1
Description of health condition studied
Dentofacial anomalies
ICD-10 code
K07
ICD-10 code description
Dentofacial anomalies [including malocclusion]
Primary outcomes
1
Description
Moderate or severe pain
Timepoint
90 days
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
60 calcium fort tablets, one tablet daily for 2 months
Category
Treatment - Drugs
2
Description
60 Acetaminophen tablets, one tablet daily for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic clinic
Full name of responsible person
Soghra Yassaei
Street address
Atlasi Square, Shahid Ghandi Blvd.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical sciences and Health Services
Full name of responsible person
Soghra Yassaei
Street address
Bahonar Square, Sadoughi Blvd.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical sciences and Health Services
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
Dental School
Full name of responsible person
Soghra Yassaei
Position
Associate Professor
Other areas of specialty/work
Street address
Dahaye Fajr Blvd, Emam AVE, Dental School, Orthodontic Department
City
Yazd
Postal code
Phone
+98 913 153 4437
Fax
Email
syassaei@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental school
Full name of responsible person
Soghra Yassaei
Position
Associate Professor
Other areas of specialty/work
Street address
Dahaye Fajr Blvd, Dental School, Orthodontic Department
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
syassaei@ssu.ac.ir syassaei@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)