Assessing the effects of micro-osteoperforation on the rate of tooth movement.
Design
Randomised, superiority, parallel group trial with simple randomization and concealed randomization using opaque envelopes.
Settings and conduct
The study was conducted in the department of orthodontics, school of dentistry at Mashhad University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 18-45 years of age; probing depth less than 3 mm
Exclusion Criteria: systematic disease; poor oral hygiene; history of long-term use of Phenytoin, Cyclosporin, systemic corticosteroids and bisphosphonates; evidence of bone resorption; history of periodontal disease; smoking
Intervention groups
Control Group: Canine retraction towards the extracted first premolar space
Intervention Group: Canine retraction towards the extracted first premolar space in addition to three micro-osteoperforations in distal of canine with at least five millimeters of depth and 2mm space between them. The MOP is performed right before canine retraction and four and eight weeks after the beginning of canine retraction.
Main outcome variables
The amount of canine movement in relation to the first molar before retraction and 2, 4, 6, 8, 10 and 12 weeks after the beginning of retraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171220037973N1
Registration date:2018-10-11, 1397/07/19
Registration timing:registered_while_recruiting
Last update:2018-10-11, 1397/07/19
Update count:0
Registration date
2018-10-11, 1397/07/19
Registrant information
Name
Erfan Bardideh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
bardidehe951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-18, 1397/06/27
Expected recruitment end date
2018-10-29, 1397/08/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of micro-osteoperforation on the rate of orthodontic tooth movement. A randomized clinical trial
Public title
Effect of micro-osteoperforation on rate of tooth movement.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Periodontal probing depth ≤3 mm
18-45 years of age
Exclusion criteria:
Existence of a systematic disease
Poor oral hygiene
History of long-term use of Phenytoin, Cyclosporine, systemic corticosteroids and Bisphospohonates
Evidence of bone resorption
History of periodontal disease
Smoking
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
2
Two different samples, one the rate of movement of the left canine and the right canine would be attributed to each person
Randomization (investigator's opinion)
Randomized
Randomization description
A five digit number would be allocated to each patient and after simple randomization using a statical software, allocation concealment would be done using opaque white envelopes.
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
Vakilabad blvd, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.008
Health conditions studied
1
Description of health condition studied
Orthodontic tooth movement
ICD-10 code
M26.4
ICD-10 code description
Malocclusion, unspecified
Primary outcomes
1
Description
Canine tooth movement in relation to first molar
Timepoint
Right before retraction and 2, 4, 6, 8, 10 and 12 weeks after retraction.
Method of measurement
Using a digital caliper with 0.2 mm accuracy the distance between the tip of canine and the mesiobuccal cusp of the first molar and also the distal of the canine bracket and mesial of the molar tube will be measured.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Three micro-osteoperforations will be made on the distal of the left and right canines using a miniscrew (self-threading (1.2x6 mm Jeil, Korea)). The perforations will be 2 mm apart and will have at least a 5mm depth. The process will be done under local anesthesia (lidocaine with 1:100,000 epinephrine 2%). The location for MOP and their distance from each other will be measured using a periodontic probe. If there is any discomfort, the patient is advised to take acetaminophen for pain management. Then the canines will be retracted using a 150g Ni-Ti close spring between canine and first upper molars' hooks. The MOPs will be repeated at 4 and 8 weeks later and the tooth movement will be measured at every 2 weeks.
Category
Treatment - Other
2
Description
Control group: Canines of these patients will be retracted using a 150g Ni-Ti close spring which will be placed between canine's hook and the first molars' tube on a 19X25 stainless steel arch wire.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic Department of the Mashhad University of Medical Science
Full name of responsible person
Mostafa Abtahi
Street address
Vakilabad blvd, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Phone
+98 51 3841 2081
Email
abtahim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
No, 18 Daneshgah Ave, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9185836393
Phone
+98 51 3841 2081
Email
tafaghodim@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
Erfan Bardideh
Position
Orthodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 274/1, 35th Seyed Razi Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9971963543
Phone
+98 51 3882 9501
Fax
Email
bardidehe951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Erfan Bardideh
Position
Orthodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 274/1, 35th Seyed Razi Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9971963543
Phone
+98 51 3882 9501
Fax
Email
bardidehe951@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Erfan Bardideh
Position
Orthodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 274/1, 35th Seyed Razi Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9971963543
Phone
+98 51 3882 9501
Fax
Email
bardidehe951@mums.ac.ir
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
Yes - There is a plan to make this available
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
Only primary outcome measures will be shared.
When the data will become available and for how long
About 1 year after the data summary have been published.
To whom data/document is available
Everybody who makes an inquiry, regardless of academic or business employees.
Under which criteria data/document could be used
The data for use in systematic reviews and meta-analyses, after assessment by Erfan Bardideh will be made available.
From where data/document is obtainable
The people who want access to the data can contact relevorance@yahoo.com for inquiry.
What processes are involved for a request to access data/document
After providing the title and protocol for the systematic review, or the protocol number in Prospero, the data will be available in a maximum of one month.