Investigating the effect of micro-osteoperforation on the rate of orthodontic tooth movement.
Design
Randomized clinical trial, split mouth, 40 patients, blinded outcome assessment and data analysis with simple Randomization and concealed randomization using sealed envelopes.
Settings and conduct
Study will performed prospectively at school of dentistry, Kermanshah University of Medical Sciences. Following leveling and alignment, miniscrews will be inserted between maxillary second premolar and maxillary first molar. Upper jaws of patients will be scanned to make digital models and 5 micro-osteoperforations (3 micro-steoperforations (MOPs) in buccal plate and 2 MOPs in palatal plate) will be made using Orthonia screwdriver (Jail) 3 mm distal to canine of intervention group. Perforations have 1.6 mm width and 3-4 mm depth.The maxillary canines of both sides of maxilla will be retracted by using Closed coil spring (150 g, 6 mm). One, two, three, four and five months after retraction, upper jaws of patients will be scanned and the models will be superimposed (Ceramill software) on baseline models to assess the amount of canine movement. Data analyzer and outcome assessor will be blind to the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Class II division I malocclusion; 16-25 years of age; Female patients
Exclusion criteria; Craniofacial disorders; Systemic disorders; Smoking; Poor oral hygiene; High buccal frenum; Lack of adequate attached gingiva; Gingivitis
Intervention groups
Intervention Group: Canine retraction towards the extracted first premolar space in addition to five micro-osteoperforations in distal of canine with 3-4 mm of depth and 2mm space between them.
Control Group: Canine retraction towards the extracted first premolar space.
Main outcome variables
The rate of canine movement 1, 2, 3, 4 and 5 months after the beginning of retraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190710044168N1
Registration date:2019-08-02, 1398/05/11
Registration timing:prospective
Last update:2019-08-02, 1398/05/11
Update count:0
Registration date
2019-08-02, 1398/05/11
Registrant information
Name
Parzhin Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3722 2400
Email address
parzhin.moradi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of alveolar bone micro-osteoperforation on the rate of orthodontic tooth movements
Public title
Investigating the effect of micro-osteoperforation on the rate of tooth movements
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class II division I malocclusion
16-25 years of age
Female patients
Exclusion criteria:
Craniofacial disorders
Systemic disorders
Smoking
Poor oral hygiene
High buccal frenum
Lack of adequate attached gingiva
Gingivitis
Insufficient distance between roots
Age
From 16 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Two different samples would be attributed to each person: the rate of maxillary left canine movement and the rate of maxillary right canine movement.
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization would be accomplished by using simple randomization method. The intervention will be randomly allocated to either the right or left side with a 1:1 allocation ratio. Each patient will be asked to pick a sealed envelope which includes a letter A or B (A: right B: left) to assign the intervention to either the right or left side.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of either patient or clinician is not possible. Blinding would be accomplished at the data collection stage, in which the outcome assessor is blinded to where the micro-osteoperforation will be applied. Also, statistical analysis will be performed by an expert who is blind to the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
split mouth design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Vice Chancellor for Research and Technology, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti Boulverd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2019-06-22, 1398/04/01
Ethics committee reference number
IR.KUMS.REC.1398.234
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
Rate of canine movement
Timepoint
Right before retraction, 1, 2, 3, 4 and 5 months after canine retraction
Method of measurement
The digital models at first, second, third, fourth and fifth months will be superimposed on the baseline 3D model and the distance between the middle projection from the distal surface of canine in baseline model and the middle projection from distal surface of the models at month 1, 2, 3, 4 and 5 will be measured using Ceramill software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Five micro-osteoperforations (3 micro-osteoperforations (MOP)s in buccal plate and 2 MOPs in palatal plate) will be made using Orthonia, Jail company with DC 2.4 v handpiece and straight type driveholder at 3 mm distal to canine. Perforations will have 1.6 mm width and 3-4 mm depth. The process will be done under local anesthesia (lidocaine with 1:100000 epinephrine 2%). Acetaminophen will be advised to control the pain. The maxillary canine will be retracted by using Closed coil spring (150 g, 6 mm) connecting the maxillary canine bracket to the miniscrews between the maxillary second premolar and first molar.
Category
Treatment - Other
2
Description
Control group: The maxillary canine will be retracted by using Closed coil spring (150 g, 6 mm) spring connecting the maxillary canine bracket to the miniscrews between the maxillary second premolar and first molar.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Dr. Amin Golshah
Street address
Across from the post office, above Shora st, Dr Shariati st
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
amin.golshah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice Chancellor for Research and Technology, Building No.2, Kermanshah University of Medical Sciences, Shahid Beheshti Boulverd
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Parzhin Moradi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Across from the post office, above Shora st, Dr Shariati st
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
parzhin.moradi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amin Golshah
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Across from the post office, above Shora st, Dr Shariati st
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
amin.golshah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parzhin Moradi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Across from the post office, above Shora st, Dr Shariati st
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
parzhin.moradi@kums.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available