Evaluation of the efficiency of the new miniscrew assisted method of protracting the mandibular second molars in patients referred to the orthodontic department
Evaluation of the efficiency of the new method of bringing forward the second molar of the lower jaw with the help of mini-screw compared to the conventional method
Design
A clinical trial with a control group, with parallel groups, without blinding, stratified, on 20 patients, which is used for randomization using pass11 software.
Settings and conduct
This study will follow a randomized controlled trial design. Participants were divided into two intervention groups: mini-screw group (A) and comparison group (B). 10 participants in each group are needed to detect significant differences. The study group will include patients referred to the orthodontic department of Mashhad Dental Faculty. Participants are randomly assigned to either the miniscrew group (A) or the comparison group (B). Measurements are taken at the beginning, during the treatment and after the treatment. Descriptive statistics are used to summarize the characteristics of the participants. To analyze the data t-test are used. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients who have lost their mandibular permanent first molar teeth.
2- Patients aged between 15 and 25 years
Exclusion criteria:
1- Patients who will not want to continue cooperation.
2-Patients with mini-screw failure for the first time
Intervention groups
The intervention groups will include the following two groups:
1- Intervention group A, which includes patients who have lost their mandibular first molar and receive the new method.
2- Intervention group B (comparison) which includes patients who have lost their mandibular first molar and receive the conventional method.
Main outcome variables
The amount of second molar advancement per unit of time, the bone surface in the mesial side of the second molar after advancement, Changes in the angle of the second molar with the mandibular border
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230407057841N1
Registration date:2023-11-28, 1402/09/07
Registration timing:registered_while_recruiting
Last update:2023-11-28, 1402/09/07
Update count:0
Registration date
2023-11-28, 1402/09/07
Registrant information
Name
lohrasb dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 4473
Email address
lohrasbbio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-11, 1402/03/21
Expected recruitment end date
2024-10-12, 1403/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficiency of the new miniscrew assisted method of protracting the mandibular second molars in patients referred to the orthodontic department
Public title
Evaluation of the efficiency of the new miniscrew assisted method of protracting the mandibular second molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Orthodontic patients who have lost their mandibular first molars and the second molars are tilted to the edentulous area and need protraction.
15-25 years old
The buccolingual thickness of the bone in the edentulous area should be more than two thirds of the buccolingual thickness of the mesial root of the second molar.
Absence of systemic problems affecting bone metabolism
No smoking
Not taking drugs affecting bone metabolism
Exclusion criteria:
Patient non-cooperation
Mini screw failure once
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The type of study is a clinical trial, which includes two control groups and patients. After the patients enter this study, they are randomly assigned to one of two intervention or control groups. The randomization of these patients will be simple randomization. Simple randomization is done by randomizer.org. Also, to conceal each person's chosen group, we write the relevant groups on paper and put them inside the envelope. Numbers are printed on the envelope according to the numbers generated by randomizer.org. Then people randomly pick one of the envelopes and are assigned to the group written inside the envelope.
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 Mashhad University of Medical Sciences
Street address
no.9,bahonar Ave.,vakilabad blvd.,mashhad town
City
mashhad
Province
Razavi Khorasan
Postal code
9177944841
Approval date
2023-04-13, 1402/01/24
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1402.014
Health conditions studied
1
Description of health condition studied
mandibular first molar loss
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mandibular second molar protraction speed
Timepoint
6 months after molar protraction
Method of measurement
Comparison of the distance of the maximum convexity of the second molar and second premolar teeth in the initial and final opg photos
Secondary outcomes
1
Description
The change of mandibular second molar angle with the mandibular border (in OPG images) before and after treatment
Timepoint
6 months after protraction
Method of measurement
OPG photos prepared
2
Description
Changes in rotation relative to the mandibular occlusion line (in study models) before and after treatment
Timepoint
6 months after protraction
Method of measurement
OPG photos prepared
3
Description
The amount of bone and its density in the mesial second molar (in CBCT images) before and after treatment
Timepoint
6 months after protraction
Method of measurement
CBCT photos prepared
Intervention groups
1
Description
Intervention group: two G2 Jeil 1.4 ⁕8 miniscrews will be placed in the mesial and distal of the second premolar tooth. Then uprighting is done with the help of a rectangular loop made of 17 ⁕25 mil TMA wire, which is placed in the screw slots, and after placing a T.Loop made of 17 ⁕25 mil TMA wire along with a 40 degree β bend and a bend Antirotation 30 degrees teeth are brought forward
Category
Treatment - Devices
2
Description
Control group: Conventionally, after the initial alignment and placing of the steel wire 25x19, a mini screw G2 Jeil 1.4 ⁕8 is placed between the 3rd and 4th teeth and connected to the 4th tooth with a ligature wire. We use Ni-Ti push coils to straighten the second molar. Then, this tooth is connected to tooth 4 with a Ni-Ti close coil spring from the buccal (bracket) and lingual (lingual button) sides with a force of 100 grams. Lingual force is applied to prevent the rotation of the second molar
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Faculty of Dentistry, Mashhad
Full name of responsible person
lohrasb dehghani
Street address
Vakil Abad Boulevard, corner of Park Square, Mashhad School of Dentistry, second floor
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
lohrasbbio@gmail.com
2
Recruitment center
Name of recruitment center
Department of Orthodontics, Faculty of Dentistry, Mashhad
Full name of responsible person
lohrasb dehghani
Street address
Vakil Abad Boulevard, corner of Park Square, Mashhad School of Dentistry, second floor
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
lohrasbbio@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr.majid ghayour mobarhan
Street address
University Street - Qureshi Building - Building No. 2 - 2nd Floor
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
lohrasbbio@gmail.com
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
Dr.fahimeh farzanegan
Position
associate professor
Latest degree
Master
Other areas of specialty/work
orthodontics
Street address
Vakil Abad Blvd., corner of Park Square, Mashhad Dental College, Orthodontics Department
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
farzaneganf@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.fahimeh farzanegan
Position
associate professor
Latest degree
Master
Other areas of specialty/work
orthodontics
Street address
Vakil Abad Blvd., corner of Park Square, Mashhad Dental College, Orthodontics Department
City
mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
farzaneganf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Lohrasb Dehghani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthodontics
Street address
No9,bahonar Ave,vakil abad blvd,mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3881 4473
Fax
Email
lohrasbbio@gmail.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