The Effect of Combination of Micro-osteoperforation and a Vibration Device on Inflammatory Factors IL-1β, RANKL, CCL2, and TNF-α in Orthodontic Tooth Movement: A Prospective Randomized Clinical trial
The Effect of Combination of Micro-osteoperforation and a Vibration Device on Inflammatory Factors IL-1β, RANKL, CCL2, and TNF-α in Orthodontic Tooth Movement
Design
Controlled clinical trial with parallel group, single-blind, randomized, on 20 patients. Excel software rand function was used for randomization
Settings and conduct
Three months after the first premolars are extracted, canine retraction begins in both groups. MOPs are performed in the buccal and palatal region distal to the canine teeth just before canine retraction. Patients in the experimental group also use a vibrating device from the initial stage of retraction, 5 minutes a day. GCF is collected before orthodontic treatment, immediately before canine retraction, 24 hours later, 7 days later, and 28 days later. Immediately the paper strips are transferred to plastic vials containing Tris Buffer solution. Vials containing samples are sent to the immunology laboratory to measure inflammatory factors .
Participants/Inclusion and exclusion criteria
Age range (18 to 45 years); canine fully erupted; Need to extract both first maxillary premolars; Existence of 3 mm space after initial alignment; Good oral hygiene
Intervention groups
The experimental group receives MOPs on both sides of the maxilla using a C-shaped vibrating device.
The control group receives MOPs on both sides (right and left) of the maxilla without the use of a vibrating device.
Main outcome variables
impact on the treatment duration ; Impact on complications due to prolonged orthodontic treatment time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200928048869N1
Registration date:2020-11-05, 1399/08/15
Registration timing:prospective
Last update:2020-11-05, 1399/08/15
Update count:0
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
Hanane Ghadirian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4500
Email address
h-ghadirian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Combination of Micro-osteoperforation and a Vibration Device on Inflammatory Factors IL-1β, RANKL, CCL2, and TNF-α in Orthodontic Tooth Movement: A Prospective Randomized Clinical trial
Public title
The Effect of Combination of Micro-osteoperforation and a Vibration Device on Inflammatory Factors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-45
erupted canines
need for extraction first maxillary premolars
at least 3 mm space after initial alignment
good oral hygiene
Exclusion criteria:
systematic disease which have effect on bone metabolism
taking medication
periodontal disease
smoking
pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Balanced Block Randomization (In this method, blocks are formed based on the considered variables and within each block, half of the intervention people and half are considered as controls).
Randomization unit: individual
Randomization tool: Microsoft Excel
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer is blind and does not know which group the results belong to
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Dentistry faculty of Tehran university of medical science, North Karegar, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Approval date
2020-07-29, 1399/05/08
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1399.058
Health conditions studied
1
Description of health condition studied
orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increased expression of inflammatory factors(IL-1β, RANKL, CCL2 and TNF-α) following the use of vibration in orthodontic patients who received MOP.
Timepoint
immediately before canine retraction, 24 hours later, 7 days later, and 28 days later
Method of measurement
ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group receives MOPs on both sides (right and left) of the maxilla using a C-shaped vibrating device (Vpro5, Propel Orthodontics).
Category
Other
2
Description
Control group: Receives MOPs on both sides (right and left) of the maxilla without the use of a vibration device.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Tehran university of medical science, Orthodontics department
Full name of responsible person
Hanane Ghadirian
Street address
Orthodontics department, Dentistry faculty of Tehran university of medical science, North Karegar, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
dentistry@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Research Institute of Tehran University of Medical Science
Full name of responsible person
Mohamadsadegh Ahmadakhoundi
Street address
Dental Research Institute, School of Dentistry, Ghods St, Enqelab St
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 8338 4320
Fax
Email
info@dri.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Institute of Tehran University of Medical Science
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
Tehran University of Medical Sciences
Full name of responsible person
Hanane Ghadirian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
Dr.h.ghadirian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanane Ghadirian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
Dr.h.ghadirian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanane Ghadirian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
Dr.h.ghadirian@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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Individual data of participants including age, sex, type of malocclusion and data obtained from the study such as the effect of intervention on inflammatory factors.
When the data will become available and for how long
6 months after publication of article
To whom data/document is available
scientific members of university of medical science
Under which criteria data/document could be used
data extraction for systematic review
From where data/document is obtainable
Applicants can get help from the corresponding author (Dr. Hananeh Ghadirian).
Postal address: Department of Orthodontics, School of Dentistry, Tehran University of Medical Sciences, North Karegar
Postal code: 1439955991
Email address: Dr.h.ghadirian@gmail.com
What processes are involved for a request to access data/document
After receiving of the request and consultation with first and corresponding author, we will inform the researcher within a month.