this study aimed to determine the effect of 980 nm diode laser irradiation on mini-screw stability and the concentration of IL-1B and TGF-B1 in PMCF at four time points following mini-screw placement.
Design
This study had a split-mouth design in order to decrease the confounding factors. LLLT was performed by the second examiner in a double-blind fashion such that the patient and the first examiner were blinded to the group allocation of each quadrant and the selected quadrant for laser therapy. Selection of the maxillary quadrant for laser therapy was done randomly by the second examiner. Laser was also used for the control quadrant with the same timing but in off mode.
The primary stability of mini-screws was measured using Periotest M .
PMCF samples were collected to measure the concentration of IL-1B and TGF-B1.
Settings and conduct
the research will done in orthodontic department of the Faculty of dentistry of Shahid Sadoughi University of Medical Sciences
Participants/Inclusion and exclusion criteria
- Patients requiring extraction of maxillary first premolars and anterior retraction.
Intervention groups
Laser was irradiated for 30 s to the occlusal and 30 s to the gingival part of the mini-screw during four cycles in the laser group. Selection of the maxillary quadrant for laser therapy was done randomly by the second examiner (laser group). Laser was also used for the control quadrant with the same timing but in off mode. By doing so, the patients were blinded to the group allocation of quadrants. Laser was irradiated at four time points of T0 (at the time of placement of mini-screw), T1 (at 1 week), T2 (at 1 month) and T3 (at 3 months).
Main outcome variables
The primary stability of mini-screws will measure with Periotest M .
Inflammation around the mini-screws will evaluate by measuring the concentration of IL-1β and TGF-β1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191008045028N1
Registration date:2019-12-11, 1398/09/20
Registration timing:retrospective
Last update:2019-12-11, 1398/09/20
Update count:0
Registration date
2019-12-11, 1398/09/20
Registrant information
Name
Somaye Kordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 2222
Email address
s.kordi3314@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-11, 1398/03/21
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-06-20, 1398/03/30
Trial completion date
2019-10-15, 1398/07/23
Scientific title
Effect of 980 nm diode laser irradiation on pro-inflammatory cytokines and mini-screw stability
Public title
Effect of diode laser irradiation on pro-inflammatory cytokines and mini-screw stability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bimaxillary dentoalveolar protrusion or class II division I malocclusion requiring extraction of maxillary first premolars and anterior retraction.
Good oral hygiene
Signing the informed consent forms by the patients or their parents
Exclusion criteria:
systemic disease
history of extraction of other permanent teeth
taking medications affecting the level of pro-inflammatory cytokines such as non-steroidal anti-inflammatory drugs and corticosteroids during the study period or in the past one month prior to the onset of treatment
periodontal disease or radiographic evidence of bone loss
pregnancy during the orthodontic treatment
Age
From 15 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
12
Actual sample size reached:
11
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done.the side of laser irradiation and the control side is determined by the coin toss of each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Banding and bonding of teeth perform by the first examiner for all patients. Low level laser perform by the second examiner in a double-blind fashion such that the patient and the first examiner blind to the group allocation of each quadrant and the selected quadrant for laser therapy.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid sadoughi University of Medical Sciences
Street address
Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
89195/165
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.SSU.REC.1397.031
Health conditions studied
1
Description of health condition studied
patients with class II division I malocclusion or bimaxillary protrusion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary stability of mini-screws
Timepoint
at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months).PTV was measured at the above mentioned four time points and one hour after laser irradiation
Method of measurement
The primary stability of mini-screws was measured by Periotest M and reported as Periotest value (PTV). At each time point, samples were collected from the PMCF to assess the concentration of IL-1B and TGF-B1
2
Description
Inflammation around the mini-screws
Timepoint
at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months).The samples were collected at the aforementioned four time points and one hour after laser irradiation and prior to the measurement of PTV
Method of measurement
PMCF samples were collected using high-purity filter papers used as paper strips to measure the concentration of IL-1β and TGF-β1.A cotton roll was used for isolation of the area and the mini-screw site was dried with air spray for 15 seconds. The paper strip was inserted into the gingival sulcus around the mini-screw and remained there for 60 s. If the Periostrip was contaminated with blood or saliva, sampling was repeated. Immediately after PMCF collection, the paper strips were transferred into sterile 1.5 mL microtubes containing 250 µL of phosphate buffered saline. Parafilm (Bemis; Neenah, Wisconsin, USA) was used to seal the tubes. The vials were stored at -20°C until collection of all samples and onset of experiment. The PMCF samples were used to measure the concentration of IL-1β using a kit designed for this purpose (Diaclone SAS, Besancon, France) and TGF-β1 using the respective kit (IBL International GMBH, Germany) by enzyme-linked immunosorbent assay according to the manufacturers’ instructions.
Secondary outcomes
1
Description
At each time point, samples were collected from the PMCF to assess the concentration of IL-1B and TGF-B1
Timepoint
at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months)
Method of measurement
The PMCF samples were used to measure the concentration of IL-1B using a kit designed for this purpose (Diaclone SAS, Besancon, France) and TGF-B1 using the respective kit (IBL International GMBH, Germany) by enzyme-linked immunosorbent assay according to the manufacturers’ instructions
Intervention groups
1
Description
Intervention group:Mini-screws were placed between the roots of maxillary second premolar and first molar. Diode laser was irradiated with 980 nm wavelength and 100 mW output power in continuous-wave mode for 30 seconds to the occlusal and 30 seconds to the gingival part of the mini-screw at four time points: T0 (1 h after mini-screw placement), T1 (1 week later), T2 (at 1 month) and T3 (at 3 months) in one quadrant of the maxilla (laser group).
Category
Treatment - Devices
2
Description
Control group: Simultaneously the other quadrant of the maxilla underwent pseudo-application of laser .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontics Department of School of Dentistry, Yazd Shahid Sadoughi University of Medical Sciences.
Full name of responsible person
Soghra Yassaei
Street address
Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3621 2222
Fax
+98 35 3625 0344
Email
s.kordi3314@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3621 2222
Fax
+98 35 3625 0344
Email
s.kordi3314@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Somaye Kordi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontic, Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3621 2222
Fax
+98 35 3625 0344
Email
S.kordi3314@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Somaye Kordi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontic, Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3621 2222
Fax
+98 35 3625 0344
Email
S.kordi3314@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Somaye Kordi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Orthodontic, Faculty of Dentistry, Dahaye Fajr BLV, Imam Ave, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
89195/165
Phone
+98 35 3621 2222
Fax
+98 35 3625 0344
Email
S.kordi3314@yahoo.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
Undecided - It is not yet known if there will be 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
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To promote motivation and science
From where data/document is obtainable
s.kordi3314@yahoo.com
somaye kordi
What processes are involved for a request to access data/document