Clinical comparison of two Initial archwires (A.NITI and HANT) for amount of tooth alignment and perception of pain-
Randomize, double blind(patients and analyzers) , without placebo, Multicenter, Phase two trials
Fix orthodontics patient in Hamadan dental College and Health centers
main inclusion criteria:Non-extraction treatment plan in lower arch؛
12-25 years old patient with crowding in anterior segment of lower arch؛Irregularity index ˃2 in lower arch
Main exclusion criteria:systemic disease influencing on pain
؛choronic NSAID therapy؛exsisting of block out teeth limiting bonding of bracket on teeth
60 case sample size
first intervention group: using of superelastic NITI(0/014) for 4 weeks
secondry intervention group: using of HANT (0/016) for 4 weeks
Year1395
primary outcome: difference of Irregularity index pre-treatment with after 4weeks
secondry outcome:The degree of pain (based on modified McGill questionnaire (MPQ)) of patint in groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041327362N1
Registration date:2016-06-05, 1395/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-05, 1395/03/16
Registrant information
Name
Majid Mahmoodzade
Name of organization / entity
Dental college
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0262
Email address
mahmoodzadeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Government ( School of Dentistry, Hamedan )
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Comparison of Two Initial Archwires (A.NITI and HANT) For Amount of Tooth Alignment and Perception of Pain- A Randomized Clinical Trial
Public title
Clinical Comparison of Two Initial Archwires For Amount of Tooth Alignment and Perception of Pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:The patient has a permanent full Dentition ( with the exception of the second and third molars )؛Non-extraction treatment plan in lower arch؛
12-25 years old patient with crowding in anterior segment of lower arch؛Irregularity index ˃2 in lower arch؛ no expansion phase or distalization in the lower jaw in the process of implementing the study is done ؛no missing or spacing in lower arch
exclusion criteria:active periodontal disease؛History of previous orthodontic treatment.؛systemic disease influencing on pain؛choronic NSAID therapy؛exsisting of block out teeth limiting bonding of bracket on teeth؛Patients with a history of dental pain , mucosal ulcers, TMD
Age
From 12 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences and Health Services
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pzhvhsh Crossroads
City
Hamadan
Postal code
654178-38741
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.UMSHA.REC.1395.44
Health conditions studied
1
Description of health condition studied
Dental Crowding
ICD-10 code
R00-R99
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Irregularity Index
Timepoint
4 weeks
Method of measurement
Caliper-Milimeter
Secondary outcomes
1
Description
Pain
Timepoint
4 weeks
Method of measurement
Modified McGill Questionaire
Intervention groups
1
Description
Intervention group:
using of 0/014 NITI superelastic wire
Category
Treatment - Devices
2
Description
Intervention group: using of 0/016 HANT wire
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental College
Full name of responsible person
Dr.Fatemeh Azizi
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pzhvhsh Crossroads
City
Hamadan
2
Recruitment center
Name of recruitment center
Special Clinic of Dental College
Full name of responsible person
Dr.Fatemeh Azizi
Street address
Front of Convenience stores, Palestine Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Hamadan University of Medical Sciences
Full name of responsible person
Dr.Amirfarhang Miresmaeili
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pzhvhsh Crossroads
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Hamadan 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
Name of organization / entity
Dental College
Full name of responsible person
Dr. Fatemeh Azizi
Position
Professional Doctorate in Dentistry
Other areas of specialty/work
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pzhvhsh Crossroads
City
Hamadan
Postal code
654178-38741
Phone
+98 81 3839 2559
Fax
+98 81 3838 1085
Email
3889AZIZI3889@gmail.com
Web page address
umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental College
Full name of responsible person
Dr.Fatemeh Azizi
Position
Professional Doctorate in Dentistry
Other areas of specialty/work
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pzhvhsh Crossroads
City
Hamadan
Postal code
654178-38741
Phone
+98 81 3839 2559
Fax
+98 81 3838 1085
Email
3889azizi3889@gmail.com
Web page address
umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Dental College
Full name of responsible person
Dr.Fatemeh Azizi
Position
Professional Doctorate in Dentistry
Other areas of specialty/work
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pzhvhsh Crossroads
City
Hamadan
Postal code
654178-38741
Phone
+98 81 3839 2559
Fax
+98 81 3838 1085
Email
3889azizi3889@gmail.com
Web page address
umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)