Identifying the most efficient arch wire in terms of speed correction of crowding and pain
Design
This study was a randomized, 2-arm, parallel, double blinded clinical trial with 88 participants.
Settings and conduct
Patients in need of fixed orthodontics treatment are randomly divided into two intervention group.The brackets and the bands of MBT 0.022 system are used. The method of the bracket positioning is similar. The wire is engaged in all teeth with elastomeric ligature. Alginate impression of lower arch is taken and plaster casts are made. After 6 weeks of bonding sessions, the impression is repeated again.Then on the primary and secondary casts, irregularity Index is measured for anterior segments. At the end of bonding session, the modified McGill Pain Questionnaire is given to all subjects and asked to fill it out until the next appointment. In this double blinded study, patients and researchers are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria are as follows: patients with permanent dentition (with the exception of the second and third molars);
non-extraction treatment plan in lower arch, 12–25 years old; patients with crowding in anterior segment of lower arch; irregularity Index greater than 2 in lower arch; no expansion phase or distalisation in the lower arch in the process of the study, and no missing or spacing in lower arch.
Exclusion criteria are as follows: active periodontal disease; history of previous orthodontic treatment, systemic disease
influencing pain, chronic NSAID therapy; blocked teeth limiting brackets bonding on teeth or engagement of the wire, and
patients with a history of dental pain, mucosal ulcers or temporomandibular disorders.
Intervention groups
Intervention group: 1-This group received A.NiTi 0.014 inch wires; 2-This group received Cu.NiTi 0.014 inch wires.
Main outcome variables
Irregularity Index; pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190705044102N1
Registration date:2019-09-26, 1398/07/04
Registration timing:prospective
Last update:2019-09-26, 1398/07/04
Update count:0
Registration date
2019-09-26, 1398/07/04
Registrant information
Name
Fatemeh Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3727 7163
Email address
fatemeh.azizi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison of two Initial arch wires (A.NiTi and Cu.NiTi) for amount of tooth alignment and perception of pain: A Randomized Clinical Trial
Public title
Clinical comparison of two Initial arch wires for amount of tooth alignment and perception of pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-extraction orthodontic treatment plan in lower arch
Patients with permanent dentition (with the exception of the second and third molars
Patients aged 12-25 years
Patients with crowding in anterior segment of lower arch
Irregularity Index > 2 in lower arch
No expansion phase or distalization in the lower arch in the process of the study
No missing or spacing in lower arch.
Exclusion criteria:
Active periodontal disease
History of previous orthodontic treatment
Systemic disease influencing pain
Chronic NSAID therapy
Blocked teeth limiting brackets bonding on teeth or engagement of the wire
Patients with a history of dental pain, mucosal ulcers or temporomandibular disorders.
Age
From 12 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The method of the randomization was stratified by age (12–
17.99 and 18–25 years) and sex, with permuted blocks (fixed
block size of 8). Allocation was concealed with numbered,
sealed and opaque envelopes containing the group allocation
cards.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this clinical trial,outcome assessor is blind about how patients are assigned.Participants in the study are also blind toward their own group while they are aware of similar costs and benefits of each arch wires.In other words, the participants will be unaware of the nature of the arch wires used.Statistical analyst is unaware about the research hypothesis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshsh University of Medical Sciences
Street address
Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.KUMS.REC.1398.632
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
Before intervention and 6 week after intervention.
Method of measurement
Caliper- millimeter
Secondary outcomes
1
Description
Pain
Timepoint
6 week after intervention
Method of measurement
The modified McGill Pain Questionnaire
Intervention groups
1
Description
Intervention group: Application of A.NiTi 0.014 inch wires as initial arch wire
Category
Treatment - Devices
2
Description
Control group: Application of Cu.NiTi 0.014 inch wires as initial arch wire
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah dental university
Full name of responsible person
Fatemeh Azizi
Street address
Shariati st.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3727 7163
Email
3889azizi3889@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for Research and Technology,Kermanshah University of Medical Sciences,Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3837 0541
Email
faridnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Aida Ekhtiari
Position
Under graduated student of dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry,Shariati st.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
0098337277163
Email
aida.extiari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Azizi
Position
Assistant Professor of Orthodontics department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontics, The School of Dentistry,Kermanshah University of Medical Sciences,Shariati st.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3727 7163
Email
3889azizi3889@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Aida Ekhtiari
Position
Under graduated student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
The school of Dentistry,Kermanshah University of Medical Sciences,Shariati st.
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3727 7163
Email
aida.extiari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available