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The evaluation of relapse, periodontal condition, and failure rates of Ortho-FlexTech™ and flatten multistrand Retainers in mandible, After orthodontic treatment

Protocol summary

Study aim
Determining and comparing the relapse rate, periodontal conditions and the failure rate of fixed FlexTech Ortho and flattened multistrand retainers in the lower jaw after orthodontic treatment.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 36 patients. "Random Allocation Software" computer software was used for randomization.
Settings and conduct
In this double-blind study (evaluators, analysts), which is conducted in the Faculty of Dentistry in Mashhad; Before installing the retainer, an alginate mold is prepared as a manufacturing guide, and after installing the retainer, the resident gives health education to the patients under the supervision of the supervisor, and after 15 days, the patient's periodontal condition is recorded. In the 3-month and 6-month follow-up, re-molding is done and the amount of irregularity of the teeth and the relapse are recorded from the patient's mold, and finally intra-group and inter-group comparisons will be made.
Participants/Inclusion and exclusion criteria
A fixed orthodontic patient aged 18 to 30 years, whose treatment has been completed, with an initial crowding of more than 4-5 mm or a diastema at the beginning of treatment, is included in the study. If the patient has parafunction habits, unwillingness to cooperate, improper oral hygiene or periodontal problems, he will be excluded from the study.
Intervention groups
In one group, multistrand wire (control group) is used for fixed retainer, and in the other two groups, FlexTech Ortho steel wire and multistrand flattened wire (experimental groups) are used.
Main outcome variables
Relapse rate, periodontal conditions and failure rate of fixed retainers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240506061677N1
Registration date: 2024-06-27, 1403/04/07
Registration timing: prospective

Last update: 2024-06-27, 1403/04/07
Update count: 0
Registration date
2024-06-27, 1403/04/07
Registrant information
Name
Seyedeh Zahra Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 2081
Email address
hoseiniz4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-29, 1403/04/09
Expected recruitment end date
2024-12-29, 1403/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of relapse, periodontal condition, and failure rates of Ortho-FlexTech™ and flatten multistrand Retainers in mandible, After orthodontic treatment
Public title
Comparison of wires for fixed retainers in the lower jaw after orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fixed orthodontic patient The age range of 18 to 30 years, whose treatment has ended Initial crowding more than 4-5 mm or severe rotation of teeth or diastema and interdental space at the beginning of treatment
Exclusion criteria:
The patient has parafunction habits including bruxism and clenching Non-cooperation of the patient to attend at specified times Improper oral hygiene Gingivitis or periodontal problems
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used in this study. The way to make the random sequence will be by the computer software "Random Allocation Software". Matte envelopes will be used in the package for concealment. For allocation concealment, we use the secretarial team, who have no knowledge of the writings inside each of the non-transparent sealed envelopes written by us.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator and analyzer of the data and results will not know how the groups were assigned. Completely identical sealed envelopes, inside each of which the treatment method is specified, are selected by the computer software and the researcher performs that method for the patient.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2024-04-06, 1403/01/18
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1403.008

Health conditions studied

1

Description of health condition studied
Orthodontic treatment results
ICD-10 code
K00
ICD-10 code description
Disorders of tooth development and eruption

Primary outcomes

1

Description
Evaluation retainer failure rate
Timepoint
15 days (T0), 3 months (T1) and 6 months (T2) after removal of the fixed device, bonding of retainer and full hygiene
Method of measurement
Retainers are carefully evaluated clinically under the light of the unit with the help of a mirror and probe.

2

Description
Examination of periodontal conditions (simplified oral hygiene index, bleeding on probing, pocket depth, clinical attachment loss)
Timepoint
15 days (T0), 3 months (T1) and 6 months (T2) after removal of the fixed device, installation of retainer and full hygiene
Method of measurement
Oral mirror and periodontal index probe (CPI = Community Periodontal Index) are used.

3

Description
Evaluation the relapse rate
Timepoint
15 days (T0), 3 months (T1) and 6 months (T2) after removal of the fixed device, installation of retainer and full hygiene
Method of measurement
Before bonding the retainer and after 15 days of its bonding, an alginate mold is prepared to evaluate the rate of relapse, and the amount of irregularity of the teeth is recorded from the patient's mold. The proposed scoring method for displacement of teeth (Little's Irregularity Index) consists of linear measurement of the anatomical contact points of each mandibular incisor from the anatomical point of the adjacent tooth.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: fixed retainer of multistrand wire. They are directly connected to the lingual surface of the front teeth of the mandible. The lingual surfaces are etched, washed and dried, and passively bonded to the lingual surface of the teeth from canine to canine by GC flowable composite.
Category
Treatment - Devices

2

Description
First intervention group: Ortho FlexTech steel wire. It was recently developed by Reliance Orthodontic Products Flex-Ortho TechTM (Itasca, IL, USA). They are directly connected to the lingual surface of the front teeth of the mandible. The lingual surfaces are etched, washed and dried, and passively bonded to the lingual surface of the teeth from canine to canine by GC flowable composite.
Category
Treatment - Devices

3

Description
The second intervention group: flat multi-stranded wire. They are directly connected to the lingual surface of the front teeth of the mandible. The lingual surfaces are etched, washed and dried, and passively bonded to the lingual surface of the teeth from canine to canine by GC flowable composite.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontics department, Mashhad dental school
Full name of responsible person
Seyedeh Maryam Omidkhoda
Street address
Orthodontics department, Mashhad dental school, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
omidkhodam@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Omidkhoda
Street address
Mashhad Dental School, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 917 112 8147
Email
omidkhodam@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Omidkhoda
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 917 112 8147
Email
omidkhodam@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mustafa Shahabi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 915 513 7976
Email
shahabim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Hosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Vakil Abad Blvd., Faculty of Dentistry, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3841 2081
Fax
Email
hoseiniz4012@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data would be shared for all researchers after the participants were unidentified.
When the data will become available and for how long
The access to data will be started 6 months after publication
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding researcher (Dr Seyedeh Maryam Omidkhoda). E-mail: omidkhodam@mums.ac.ir
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission.
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