A clinical trial to compare the effectiveness of Multi-Stranded Flexible wires with Single Strand Flat Ribbon wires for lingual fixed retainers after orthodontic treatment
To compare the effectiveness of Multi-Stranded Flexible wires with Single Strand Flat Ribbon wires for lingual fixed retainers after orthodontic treatment.
Design
This randomized and double-blind clinical trial with parallel and two intervention groups will be conducted on 170 patients who will be randomly selected using the random number table.
Settings and conduct
Patients with orthodontic treatment referring to Dental Clinic of Birjand Faculty of Dentistry, Birjand, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group I will receive the Multi-Stranded Flexible wires and intervention group II will receive Single Strand Flat Ribbon wires. The care provider and responsible for data collection are blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 13-30 years; the patient is in the final stage of orthodontic treatment; fixed orthodontic treatment of the patient with Brackets MBT Mini 0.022; having Class I Malocclusion; having good oral hygiene.
Exclusion criteria: Having a deep overbite; having periodontal problems such as bleeding on probing or periodontal pockets depth greater than 3 mm.
Intervention groups
The intervention group I will receive Multi-Stranded Flexible wires from American ortho company for anterior teeth of the lower jaw splinting.
The intervention group II will receive Single Strand Flat Ribbon wires from American ortho company for anterior teeth of the lower jaw splinting.
Main outcome variables
Evaluation of the failure rate of wire, the failure rate of cement, the rate of relapse, band separation and band separation time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230602058366N1
Registration date:2023-06-06, 1402/03/16
Registration timing:prospective
Last update:2023-06-06, 1402/03/16
Update count:0
Registration date
2023-06-06, 1402/03/16
Registrant information
Name
Majid Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 3002
Email address
azizi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of Multi-Stranded Flexible wires with Single Strand Flat Ribbon wires for lingual fixed retainers after orthodontic treatment
Public title
The effectiveness of wires for lingual fixed retainers after orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 13-30 years
The patient is in the final stage of orthodontic treatment
Fixed orthodontic treatment of the patient with Brackets MBT Mini 0.022
Having Class I Malocclusion
Having good oral hygiene
Exclusion criteria:
Having a deep overbite
Having periodontal problems such as bleeding on probing or periodontal pockets depth greater than 3 mm
Age
From 13 years old to 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be simple randomly assigned to two groups using a random table type and opaque envelopes will be used for concealment
Blinding (investigator's opinion)
Double blinded
Blinding description
The care provider and responsible for data collection are blind to group allocation and the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.BUMS.REC.1402.010
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
C41.0
ICD-10 code description
Bones of skull and face
Primary outcomes
1
Description
The failure rate of wire
Timepoint
3, 6, 9, 12, 15 and 18 months after intervention
Method of measurement
Based on the number of wires broken during examination
2
Description
The failure rate of cement
Timepoint
3, 6, 9, 12, 15 and 18 months after intervention
Method of measurement
Based on the number of broken cements during examination
3
Description
The rate of relapse
Timepoint
3, 6, 9, 12, 15 and 18 months after intervention
Method of measurement
Based on the number of teeth moved during examinations
Secondary outcomes
1
Description
Band separation
Timepoint
3, 6, 9, 12, 15 and 18 months after intervention
Method of measurement
Based on the amount of tooth separation distance during examinations
2
Description
Band separation time
Timepoint
3, 6, 9, 12, 15 and 18 months after intervention
Method of measurement
Based on the time of separation of teeth during examinations
Intervention groups
1
Description
Intervention group: The intervention group I will receive Multi-Stranded Flexible wires from American ortho company for anterior teeth of the lower jaw splinting.
Category
Treatment - Devices
2
Description
Intervention group: The intervention group II will receive Single Strand Flat Ribbon wires from American ortho company for anterior teeth of the lower jaw splinting.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Birjand Faculty of Dentistry
Full name of responsible person
Majid Azizi
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Majid Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Majid Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
Razavi Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Majid Azizi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Birjand Faculty of Dentistry, Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3243 3002
Email
majid_67_a@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Majid Azizi provides the data analysis to the applicants via email: majid_67_a@yahoo.com
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.