Protocol summary

Study aim
Determination of effect of miniscrew entrance angulation in buccal area of maxillary bone of patients applicant for orthodontic treatment on clinical success rate
Design
Randomized clinical trial, 46 patients, blinded outcome assessment and data analysis with simple Randomization and concealed randomization using sealed envelopes.
Settings and conduct
The study, will be conducted as a randomized,clinical trial, in faculty of dentistry of Kermanshah University of Medical Sciences in 46 patients applicant for using miniscrews in their treatment plan in buccal plate of maxillary bone in order to retract maxillary canine into the area of extracted first premolar, are chosen.following the leveling and alighning, miniscrews are randomly placed in each side at 90 or 45 degree angles. Patients will be monitored for 6 months each month and symptoms of treatment failure, including redness, inflammation, unbearable pain, and unacceptable movement of miniscrew, as determined by the Periotest device, will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with Class II malocclusion who need canine retraction into the space of extracted first premolar. Exclusion criteria: patients with craniofacial syndromes،insufficient attached gingiva،smoking، systemic disorders and poor oral hygiene.
Intervention groups
Intervention group1: mini-screw placement on one side of patient maxillary bone in 45 angle degrees. Intervention group2 : mini-screw placement on one side of patient maxillary bone in 90 angle degrees.
Main outcome variables
success rate in miniscrew placement angulation of 45 and 90 degree angles.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190901044659N1
Registration date: 2020-02-18, 1398/11/29
Registration timing: registered_while_recruiting

Last update: 2020-02-18, 1398/11/29
Update count: 0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
kimia gorji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3722 2400
Email address
kimia.gorji@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-30, 1398/10/09
Expected recruitment end date
2020-03-12, 1398/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of miniscrew entrance angulation in buccal area of maxillary bone of patients applicant for orthodontic treatment on clinical success rate
Public title
Effect of miniscrew entrance angulation on clinical success rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class II (cl II ) malocclusion Need for canine retraction into the space of extracted first premolar
Exclusion criteria:
Existing of Craniofacial Syndromes poor oral Hygiene Existing of systemic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 46
More than 1 sample in each individual
Number of samples in each individual: 2
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization would be accomplished by using simple randomization method. in the way that an envelop containing the angle and one containing the side of placement of the miniscrew will be chosen for each patient and the patient wont be aware of this choice.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient، the outcome assesor and the statistical analyser are blinded to the miniscrew placement angle of each side.
Placebo
Not used
Assignment
Parallel
Other design features

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
2019-10-13, 1398/07/21
Ethics committee reference number
IR.KUMS.REC.1398.694

Health conditions studied

1

Description of health condition studied
Dental malocclusion
ICD-10 code
M26.4
ICD-10 code description
Malocclusion, unspecified

Primary outcomes

1

Description
Clinical success of mini-screw placement on 90 and 45 angle degrees which means lack of inflammation signs such as swelling, redness and , etc., also the absence of unbearable pain for the patient.
Timepoint
Each month over 6 months after applying orthodontic force.
Method of measurement
Using Periotest device and the visual analogue scale of pain in patient in duration of treatment.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1:Intervention group: the treatment will be done by roth system of Discovery brackets from Dentarome company,made in Germany, and American Orthodontist company bands.after leveling and alighning with Nickle- Titanium 0.16 wires and achieving 25*17 stainless still wires, mini-screrws will be placed on one side of maxilla in 45 angle degrees.
Category
Treatment - Other

2

Description
Intervention group2: the treatment will be done by roth system of Discovery brackets from Dentarome company,made in Germany, and American Orthodontist company bands.after leveling and alighning with Nickle- Titanium 0.16 wires and achieving 25*17 stainless still wires, mini-screrws will be placed on one side of maxilla in 90 angle degrees.
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
Kimia Gorji
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
kimia.gorji@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
Kimia Gorji
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
kimia.gorji@kums.ac.ir

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
Data Dictionary
Not applicable
Loading...