Comparison of the effect of the expansion with traditional and clear expansion plate on the torque of upper first molars
Design
Randomized clinical trial with two groups (A and B), each group containing 30 patients. we will use SNOSE method for allocation.
Settings and conduct
In this randomized controlled trial, the clinical effects of traditional and clear expansion plate will be compared. Sixty patients referring to the orthodontic department of the faculty of dentistry of Tabriz University of Medical Sciences and private office of the orthodontist will be selected according to the inclusion and exclusion criteria and randomly divided into two groups. Before and after six month of expansion stone models will be made and the torque of upper first molars will be measured on the models. then the before -after and inter-group comparisons will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: mixed dentition patients; the patients seeking treatment; signature of informed consent; upper arch constriction.
Exclusion criteria: lack of patient cooperation in recall sessions; poor oral hygiene; extraction of upper first molars during treatment; fracture, crown or any kind of restoration which involves the occlusal surface of the molars.
Intervention groups
Traditional expansion plate: in these patients, traditional expansion plate will be used to treat upper arch constriction.
Clear expansion plate: in these patients, clear expansion plate will be used to treat upper arch constriction.
Main outcome variables
The change in torque of posterior teeth; expansion of the upper arch
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170723035238N4
Registration date:2022-01-22, 1400/11/02
Registration timing:prospective
Last update:2022-01-22, 1400/11/02
Update count:0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
ahmad behroozian
Name of organization / entity
tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 33379351
Email address
behrooziana@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-25, 1400/11/05
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of expansion with traditional and clear expansion plate on inclination of upper molars; a randomized clinical trial
Public title
The effect of the clear expansion plate on the posterior teeth of the upper arch
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mixed dentition patients
The patients' tendency to attend in the study
Signing the informed consent form to participate in the study
Upper arch constriction
Exclusion criteria:
Poor patient cooperation in follow-up sessions
Poor oral hygiene
Extraction of upper first molars during the treatment
Fracture, crown or any kind of restoration which involve the occlusal surface of the first molars
Age
From 5 years old to 14 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
Numbered, sealed, opaque envelope (SNOSE); in this allocation system the researchers use mate envelopes. The number of the envelopes is equal with the number of the patients in each group. Then the envelops are gathered in the box. For each patients one envelope will be selected randomly and the group ( case or control ) will be selected in this way.
Blinding (investigator's opinion)
Not 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 Tabriz University of Medical Sciences
Street address
Central building of Tabriz medical university / Golgasht st. / Azadi st.
City
Tabriz
Province
East Azarbaijan
Postal code
5163916737
Approval date
2022-01-03, 1400/10/13
Ethics committee reference number
IR.TBZMED.REC.1400.980
Health conditions studied
1
Description of health condition studied
Upper arch constriction
ICD-10 code
M26.4
ICD-10 code description
Malocclusion, unspecified
Primary outcomes
1
Description
The change in the toque of upper posterior teeth
Timepoint
Before treatment and 6 months later
Method of measurement
Stone casts
2
Description
Arch expansion
Timepoint
Before treatment and 6 months later
Method of measurement
Stone casts
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: clear expansion plate. In This group we will use clear expansion plate for the patients who need arch expansion . Clear expansion plate is made from thermoplastic sheets which is routinely used for the fabrication of clear retainers. An expansion screw is embedded in the midpalatal region of the thermoplastic sheet. The patients will activate the screw twice a week . Each activation make separation between two halves of the appliance and expansion of the arch laterally. this expansion may change the buccolingual inclination of the posterior teeth. the buccolingual inclination of the upper first molar will be measured and compared before and after treatment. The inter-group comparison will be dene as well.
Category
Treatment - Devices
2
Description
Intervention group: traditional expansion plate.In This group we will use traditional acrylic expansion plate for the patients who need arch expansion . acrylic expansion plate is made from the wire elements and acrylic framework. An expansion screw is embedded in the midpalatal region of the acrylic framework . The patients will activate the screw twice a week . Each activation make separation between two halves of the appliance and expansion of the arch laterally. this expansion may change the buccolingual inclination of the posterior teeth. the buccolingual inclination of the upper first molar will be The inter-group comparison will be dene as well.measured and compared before and after treatment.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry / Tabriz University of Medical Science
Full name of responsible person
Ahmad Behroozian
Street address
Faculty of Dentistry/ Next to the Central building of Tabriz medical university/ Golgasht st. /Azadi st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0310
Fax
+98 41 3334 0310
Email
ahmadbehrouzian@gmail.com
2
Recruitment center
Name of recruitment center
Office Dr Ahmad Behroozian
Full name of responsible person
Ahmad Behroozian
Street address
Unit B, 3rd floor, Eskan Medical Building, Abresan
City
Tabriz
Province
East Azarbaijan
Postal code
5163916737
Phone
+98 41 3336 2055
Email
ahmadbehrouzian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Street address
Tabriz University of Medical Sciences / Golgasht st. / Azadi st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0310
Email
ahmadbehrouzian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences / Golgasht st. / Azadi st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7635
Email
ahmadbehroozian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences / Golgasht st. / Azadi st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7635
Email
ahmadbehrouzian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahmad Behroozian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences / Golgasht st. / Azadi st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 7635
Fax
Email
ahmadbehrouzian@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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 results of the study will be published in the scientific journals.
When the data will become available and for how long
2022-8-10
To whom data/document is available
Open access
Under which criteria data/document could be used
For researchers in medical sciences
From where data/document is obtainable
One can find the data in the journal which the article will be published in it.
What processes are involved for a request to access data/document
The access will be according to the policy of the journal which the article will be published in it.