The objective of this clinical trial study is to evaluate the ability of mini-screw as a micro-perforation device to accelerate canine retraction in orthodontic patients. Additionally, we will investigate the pain and discomfort of the patient during the study.
Design
The study is double blind randomized clinical trial with split mouth design.
Settings and conduct
Both maxillary canines will be retracted, and movement will be measured every 28 days in three intervals. Pain and discomfort will be monitored with a visual analogue scale.
Participants/Inclusion and exclusion criteria
Class II division 1 or Class I bimaxillary dentoalveolar protrusion
Mild or no crowding
No previous orthodontic treatment
No history of systemic disease
Good oral hygiene
No radiographic evidence of bone loss
No history of periodontal therapy and active periodontal disease
Probing depth less than 4 mm across the entire dentition
No gingivitis or active carious lesion
Gingival index and plaque index value less than 1
No smoking
Intervention groups
Ten patients with Class II Division 1 or Class I bimaxillary protrusion malocclusion will be selected. Four month after first premolar extraction, just before canine retraction micro-osteoperforation will be created in experimental side of each patient. The control side will not receive micro-osteoperforations.
Main outcome variables
rate of canine movement
pain and discomfort after micro-osteoperforation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181121041713N1
Registration date:2018-11-30, 1397/09/09
Registration timing:prospective
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
neda babanouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 0801
Email address
babanouri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of mini-screw-facilitated micro-osteoperforation on the rate of orthodontic tooth movement
Public title
effect of micro-osteoperforation on the rate of tooth movement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
orthodontic patients with Class II division 1 or Class I bimaxillary dentoalveolar protrusion malocclusion
mild or no crowding
no previous orthodontic treatment
no history of systemic disease
good oral hygiene
no radiographic evidence of bone loss or no history of periodontal therapy and active periodontal disease
probing depth less than 4 mm across the entire dentition
no gingivitis or active carious lesion
gingival index and plaque index value less than 1
no smoking.
Exclusion criteria:
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
The experimental side will be randomly selected by means of coin tosses to prevent selection bias
Blinding (investigator's opinion)
Double blinded
Blinding description
Three insertions will be created on buccal and palatal area in the control side only in gingival tissue by principle investigator, so both patients and orthodontist administering the treatment will be blind of allocation side
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
central building of Shiraz University of Medical Science, Zand st.
City
ُShiraz
Province
Fars
Postal code
7134814336
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
1396-01-37-15681
Health conditions studied
1
Description of health condition studied
rate of orthodontic tooth movement
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
rate of canine retraction
Timepoint
28 days- 56 days- 84 days
Method of measurement
electric digital caliper- Visual Analogue Scale
Secondary outcomes
1
Description
Pain after micro-osteoperforation
Timepoint
on the day of canine retraction - subsequently at 24 hours
Method of measurement
Visual Analogue Scale (VAS).
Intervention groups
1
Description
Intervention group: 1 mm micro-osteo perforation on the buccal and palatal bone
Category
Treatment - Other
2
Description
Control group: perforation only on the gingiva
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz dental school
Full name of responsible person
Mahtab Memarpour
Street address
Dental School, Ghomabad Ave., Ghasraldasht St.
City
Shiraz
Province
Fars
Postal code
713451836
Phone
+98 71 3628 0456
Fax
+98 71 3628 0801
Email
dental@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
1396-01-37-15681
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Neda Babanouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Ghom Abad Ave., Ghasraldasht St.
City
Shiraz
Province
Fars
Postal code
713541836
Phone
+98 71 3628 0801
Fax
+98 71 3628 0801
Email
nedababanouri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Babanouri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Ghomabad Ave., Ghasraldasht St.
City
Shiraz
Province
Fars
Postal code
713451836
Phone
+98 71 3628 0801
Fax
Email
babanouri@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Babanouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Ghom Abad Ave. Ghasraldasht St.
City
Shiraz
Province
Fars
Postal code
713541836
Phone
+98 71 3628 0801
Fax
+98 71 3628 0801
Email
nedababanouri@yahoo.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