A clinical trial to compare the effectiveness of miniscrew-supported appliances with pendulum appliance in maxillary first molar distalization in orthodontic patient
To compare the effectiveness of miniscrew-supported appliances with pendulum appliance in maxillary first molar distalization in orthodontic patient
Design
Totally, 30 patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using simple sampling methods
Settings and conduct
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 14-20 years; class II malocclusion; class I and class II skeletal pattern.
Exclusion criteria: Miniscrew failure; having dental and bone lesions; having periodontal disease.
Intervention groups
The intervention group will receive miniscrew-supported appliances for maxillary first molar distalization. The Control group will receive a common pendulum appliance for maxillary first molar distalization.
Main outcome variables
Evaluation and comparison of the distance between lateral incisor distal contact to molars mesial contact, upper arch dimensions, the amount of distal molar movement, rate of tooth rotation, rate of root resorption, and rate of pain before and after the intervention in the two intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047357N1
Registration date:2020-05-18, 1399/02/29
Registration timing:prospective
Last update:2020-05-18, 1399/02/29
Update count:0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Haniye Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
kazemigh971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of miniscrew-supported appliances with pendulum appliance in maxillary first molar distalization in orthodontic patient
Public title
The maxillary first molar distalization in orthodontic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 14-20 years
Class II malocclusion
Class I and class II skeletal pattern
Exclusion criteria:
Miniscrew failure
Having dental and bone lesions
Having periodontal disease
Age
From 14 years old to 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into two groups of 15 patients with blocks of 2 and 4 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Accordingly, the participants were given codes and assigned into the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs.
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
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-11-13, 1398/08/22
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.106
Health conditions studied
1
Description of health condition studied
Orthodontic
ICD-10 code
Z46.5
ICD-10 code description
Fitting and adjustment of ileostomy and other intestinal appliances
Primary outcomes
1
Description
The distance between lateral incisor distal contact to molars mesial contact
Timepoint
Before and after the intervention
Method of measurement
Cone Beam Computed Tomography (CBCT)
2
Description
Upper arch dimensions
Timepoint
Before and after the intervention
Method of measurement
Cephalometric radiograph
3
Description
The amount of distal molar movement
Timepoint
Before and after the intervention
Method of measurement
Cone Beam Computed Tomography (CBCT)
4
Description
Rate of tooth rotation
Timepoint
Before and after the intervention
Method of measurement
Cone Beam Computed Tomography (CBCT)
5
Description
Rate of root resorption
Timepoint
Before and after the intervention
Method of measurement
Cone Beam Computed Tomography (CBCT)
Secondary outcomes
1
Description
Rate of pain
Timepoint
Before and after the intervention
Method of measurement
A Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group: Intervention group will receive miniscrew-supported appliances for maxillary first molar distalization.
Category
Treatment - Devices
2
Description
Control group: Control group will receive common pendulum appliance for maxillary first molar distalization.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Haniye Kazemi
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Haniyekazemi71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@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
Haniye Kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Haniyekazemi71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Haniye Kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Haniyekazemi71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Haniye Kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
Haniyekazemi71@gmail.com
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
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
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Haniye Kazemi provides the data analysis to the applicants via email: Haniyekazemi71@gmail.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.