Determining the effect of occlusal space on the amount of relapse crowding after orthodontic treatment using T-scan III
Design
The clinical trial is a parallel groups study with two groups, single blind, randomized. Study would be conducted on 40 patients, and randomizer.org would be used for randomization.
Settings and conduct
Patients undergoing orthodontic treatment in the morning and evening shifts of Ferdowsi University who are in the final phase of their treatment and if they are eligible will be included in the study and will be randomly assigned to the intervention and control groups using the random block method. This would be a single blind study, in such a way that the analysts will not know about the study method
Participants/Inclusion and exclusion criteria
inclusion criteria:30-17 years old patient who has class 1 malocclusion problem with double jaw tooth protrusion or crowding more than 4 mm and has undergone fixed orthodontic treatment of both jaws with extraction of first premolar teeth in both arches and their treatment system is MBT0 22 and are at the end of their treatment phase
Exclusion criteria:Patients with systemic disease , improper oral hygiene , gingivitis or periodontal problems or deep caries that have spread to the cement enamel junction , taking drugs that affect bone metabolism such as drugs that prevent bone resorption, Patient with parafunction habit
Intervention groups
In the intervention group, one month after complete debonding and full-time use of the transparent retainer, occlusal adjustment (selective scraping of the surface of the teeth to remove the anterior contacts) is performed. And in the control group, occlusal adjustment is not performed.
Main outcome variables
Intercanine width
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230310057665N1
Registration date:2023-11-12, 1402/08/21
Registration timing:prospective
Last update:2023-11-12, 1402/08/21
Update count:0
Registration date
2023-11-12, 1402/08/21
Registrant information
Name
Farnaz zia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3762 0839
Email address
farnaz_ziya91@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-04-29, 1403/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of occlusal adjustment on relapse after orthodontic treatment by T-scan III
Public title
Evaluation of the occlusal adjustment on orthodontic's relaps by T-scan III
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 17-30 years of age
with class 1 dental malocclusion
with double jaw tooth protrusion or crowding more than 4 mm
underwent fixed orthodontic treatment
with extraction of 4 first premolar teeth of two jaws
underwent fixed orthodontic treatment with MBT 0.22 bracket system.
Exclusion criteria:
Patient with parafunction habit
systemic disease
poor oral hygiene
Gingivitis or periodontal problems or deep caries that have spread to the cement enamel junction
Taking drugs that affect bone metabolism, such as drugs that prevent bone resorption
Age
From 17 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation block method is used to generate random allocation sequences of people to study groups. The random assignment sequence of people is performed using random allocation software and block size two. Permutation blocks method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks AB and BA. If the first block, AB, is chosen, the first is assigned to group A and the second to group B. And this process continues until the allocation of all samples. The feature of this method is that the two study groups will have equal numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the work, the experimenter and the tested people cannot be blinded, and the people who analyze the results at the end of the work are blind. The cassettes are only given to the analyst by number.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Dentistry, Mashhad University of Medical Sciences
Street address
Dentistry faculty,in front of Mellat park,Vakilabad blv,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1401.143
Health conditions studied
1
Description of health condition studied
Investigating orthodontic relapse using T-scan III
ICD-10 code
K07.2
ICD-10 code description
Anomalies of dental arch relationship
Primary outcomes
1
Description
Intercanine width
Timepoint
Pre intervention,6months after intervention
Method of measurement
Image J software
Secondary outcomes
1
Description
Root paralleling
Timepoint
1 month before the intervention and 6 months after the intervention
Method of measurement
Image J software
Intervention groups
1
Description
Intervention group: Inclusion criteria would be patients undergoing fixed orthodontic treatment with MBT prescription brackets with bimaxillary protrusion or with 4mm crowding or more. After debonding, a plaster mold would be created from both dentitions. Then they would be instructed to use their ESSIX VFR retainers for one month full-time and one-month part-time. One-month after debonding and wearing retainers full time, occlusal adjustment would be done by selectively grinding occlusal contacts to mitigate the precursors for potential orthodontic relapse and dental relationship would be then evaluated by T-scan device. Six months after debonding, plaster casts would be made again, and dental relations would be evaluated by T-scan device. By comparing the initial and final plaster casts, relapse would be assesed.
Category
Treatment - Devices
2
Description
Control group: the conditions are completely similar to the intervention group, but after complete debonding, occlusal adjustment is not done, and patients are evaluated with a T-scan device immediately after debonding, 1 month after debonding, and 6 months after debonding, and also immediately after debonding and 6 months after debonding, casting is done with alginate and the primary and secondary casts are compared to check the amount of relaps.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Clinic of the Faculty of Dentistry and Department of Orthodontics
Full name of responsible person
Farnaz Zia
Street address
No.74,19th West Bozorgmehr,Sajjad BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
9186663977
Phone
+98 51 3762 0839
Email
Farnaz_ziya91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayourmobarhan
Street address
No 1/2 Parastar avenue, Ahmadabad avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9176698837
Phone
+98 51 3845 8772
Email
Ghayourm@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
Arezoo Jahanbin
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry,in front of Mellat park,Vakilabad BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
0098518829501
Email
JahanbinA@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Jahanbin
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry,in front of Mellat park,Vakilabad blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
JahanbinA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz Zia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.74,19th West Bozorgmehr,Sajjad BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
9186663977
Phone
+98 51 3762 0839
Email
Farnaz_ziya91@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not 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
Title and more details about the data/document
The data is reported as an average and the original data is also available
When the data will become available and for how long
The start of the access period after September 2025
To whom data/document is available
Everyone is allowed
Under which criteria data/document could be used
The use of raw data is not allowed
From where data/document is obtainable
To Farnaz Zia with mobile number 09126838974
What processes are involved for a request to access data/document