Protocol summary

Study aim
The comparison of the effect of the miniscrew-supported technique with conventional techniques in mandibular second molar uprighting in patients under orthodontic treatment
Design
Clinical trial with control group, single-blind with parallel groups, randomized on 10 patients. Table of random numbers are used for randomization.
Settings and conduct
The patients are selected from those who refer to the Dental Clinic of Mashhad, Faculty of Dentistry, Mashhad, Iran. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The intervention group will receive the miniscrew-supported approach, and the control group will receive the conventional Melsen method for the uprighting of mandibular second molars. The person responsible for data collection is blind to the group allocation and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients who have already lost their first molars, those who are candidates for prosthetic treatment of the edentulous site, along with cases whose second molars are inclined at least 30 degrees. Exclusion criteria: Those with poor oral hygiene, history of using medications, systemic diseases, hormonal imbalance, and furcation involvement will be excluded from the study.
Intervention groups
Intervention group will receive miniscrew-supported appliances for uprighting of mandibular second molars. Control group will receive conventional Melsen method for uprighting of mandibular second molars.
Main outcome variables
The time required for uprighting, speed of uprighting, the rate of tooth extrusion and the bone formation rate in the mesial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210606051499N1
Registration date: 2021-07-22, 1400/04/31
Registration timing: prospective

Last update: 2021-07-22, 1400/04/31
Update count: 0
Registration date
2021-07-22, 1400/04/31
Registrant information
Name
Mostafa Entezari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
heravif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effect of the miniscrew-supported technique with conventional techniques in mandibular second molar uprighting in patients under orthodontic treatment
Public title
The uprighting of mandibular second molars in orthodontic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who have already lost their first molars Cases whose second molars are inclined at least 30 degrees The patients who are candidates for prosthetic treatment of the edentulous site.
Exclusion criteria:
Poor oral hygiene History of using drug Having systemic disease Having hormonal imbalance Furcation involvement
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization will be used by random number table based on SAS (statistical analysis system), software. A list of sequentially number 1 to 10 will be created. This list will assign numbers randomly by computer. Patients are randomly assigned according to the numbers of this list. To conceal, we use Allocation concealment, using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients who refer to the Dental Clinic of Mashhad, Faculty of Dentistry, Mashhad, Iran, are selected 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 the group allocation and the type of treatment.
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
2021-05-15, 1400/02/25
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.032

Health conditions studied

1

Description of health condition studied
Orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device

Primary outcomes

1

Description
The time required for uprighting
Timepoint
Before and after the intervention
Method of measurement
Cone beam computed tomography, Orthopantomography and Periapical radiography images

2

Description
Speed of uprighting
Timepoint
Before and after the intervention
Method of measurement
Cone beam computed tomography, Orthopantomography and Periapical radiography images

3

Description
The rate of tooth extrusion
Timepoint
Before and after the intervention
Method of measurement
Cone beam computed tomography, Orthopantomography and Periapical radiography images

4

Description
The bone formation rate in the mesial
Timepoint
Before and after the intervention
Method of measurement
Cone beam computed tomography, Orthopantomography and Periapical radiography images

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive miniscrew-supported approach for the uprighting of mandibular second molars. In this method, a mini-screw is placed in the distal second molar, and without the need for anterior teeth placement appliance, the molar operation is performed only with the help of the number one wire.
Category
Treatment - Devices

2

Description
Control group: The control group will receive the conventional Melsen method for the uprighting of mandibular second molars. In this method, a mini-screw is placed between the seventh and fifth teeth, and the apparatus is performed with the help of one spring, and the extraction is prevented with the help of the second wire.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Mostafa Entezari
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
mostafa.entezari91@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
Mostafa Entezari
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
mostafa.entezari91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mostafa Entezari
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
mostafa.entezari91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mostafa Entezari
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
mostafa.entezari91@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
The information obtained from the main outcomes of the study can be shared
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research
From where data/document is obtainable
Mostafa Entezari provides the data analysis to the applicants via email: mostafa.entezari91@gmail.com
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.
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