Assessment the effect of low level laser(980nm) on the amount of matrix metalloproteinase-1 in gingival cervicular fluid in people undergoing fixed orthodontic treatment
Assessment the effect of low level laser therapy (LLLT) on the amount of matrix metalloproteinase-1 in the gingival crevice fluid in people undergoing fixed orthodontic treatment.
Design
This trial has a control group, with parallel groups, double-blind, randomized, phase 3 on 24 patients and split mouth. Permuted block randomization was used for randomization.
Settings and conduct
In this study, considering the biostimulatory effects of LLLT, we try to measure the amount of MMP1 changes in response to this type of laser.This study is conducted in the orthodontics department of the Yazd school of Dentistry.This is a double-blind design study, and the person responsible for data collection and the person performing the ELISA test are unaware of which group each person is in.
Participants/Inclusion and exclusion criteria
The participants include those who refer to the orthodontic department of Yazd school of Dentistry.
People should be healthy and free of any periodontal and systemic diseases and should not use any medicine. People who do not come on the scheduled date or have poor oral hygiene will be excluded from the study.
Intervention groups
Diode laser radiation (980 nm) and output power of 100 mw in continuous mode will be performed on two consecutive days on the side of the intervention, which includes the two anterior teeth of the mandible. On the opposite side of the dental arch (control), similar to the intervention side, the device is used off. Laser irradiation will be performed on three points on the buccal side and two points on the lingual side of each tooth, with intervals of two mm below the free gingiva for 10 seconds.
Main outcome variables
The level of matrix metalloproteinase-1.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210221050435N3
Registration date:2024-06-24, 1403/04/04
Registration timing:prospective
Last update:2024-06-24, 1403/04/04
Update count:0
Registration date
2024-06-24, 1403/04/04
Registrant information
Name
Hossein Aghili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1785
Email address
hosseinaghily@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of low level laser(980nm) on the amount of matrix metalloproteinase-1 in gingival cervicular fluid in people undergoing fixed orthodontic treatment
Public title
Assessment the effect of low level laser on the amount of matrix metalloproteinase-1.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals must be healthy and free of any periodontal and systemic diseases.
Individuals must need fixed orthodontic treatment.
Patients should not use any medicine.
Patients must be willing and have informed consent to participate in the study.
Exclusion criteria:
Non-attendance of patients on the scheduled date.
Failure to oral hygiene care during treatment.
The emergence of SARS-Cov-2, which prevents patients from visiting on time.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
The research will be conducted in the form of a split mouth to reduce interfering factors.
Randomization (investigator's opinion)
Randomized
Randomization description
In this type of study, randomization occurs rather than on patients, on the side of the mouth exposed to laser radiation occurs or oral areas occur. Random allocation method will be performed on a simple random type (random number list)by Random allocation software version 1.0. A randomized list will be prepared by an epidemiologist who is not involved in the implementation of the interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only the person who is responsible for the laser radiation knows how to assign people to the groups, and the person who is responsible for collecting the data and the person who performs the ELISA test are not aware of which group each person is in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Dahe Fajr Boulevard, Imam Reza Street, Shahid Sadoughi University of medical science, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1401.055
Health conditions studied
1
Description of health condition studied
Low level laser therapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
amount of matrix metalloproteinase-1 in gingival cervicular fluid
Timepoint
Assessment of matrix metalloproteinase-1, one day and one week after laser therapy
Method of measurement
Absorbent papers are used for sampling. Patient samples are measured by MMP-1 ELISA kit ZellBio.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group(includes two anterior teeth of the mandible whose side was chosen randomly), a Diode laser with a wavelength of 980 nm (Doctor Smile class 4 laser. Classification CEI EN 60825-1) which is in the infrared range and output power of 100 mw will be used in continuous mode. Laser irradiation is performed on two consecutive days to three points on the buccal side and two points on the lingual side of each tooth, with intervals of two mm under the free gingiva of the two front teeth of the mandible for 10 seconds.The cross section of the probe is 1 cm2 and energy density is 1 J/cm2 for each point.The probe of the device is placed vertically and in contact with the mucosa.Then, 24 hours and 164 hours after the intervention, sampling of the gingival crevicular fluid will be done using a Periostrip (Rundfilter, Macherey. Nagel+CO, Germany) measuring 2 x 10 mm. Periostrip remains for 30 seconds in the buccal gingival groove of the two anterior teeth of the mandible.All samples stained with saliva and blood will be removed then the samples are sent to the laboratory to perform the ELISA test and are kept in a -70'C until the test is performed.
Category
Treatment - Devices
2
Description
Control group:include the two anterior teeth of the mandible on the other side of the arch, similar to the intervention side, the device will be used off.24 hours and 164 hours after the intervention, sampling is done the same as the intervention group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, School of Dentistry, Shahid Sadoughi University of Medical Sciences, Yaz
Full name of responsible person
Hossein Agha Aghili
Street address
Dahe Fajr Boulevard, Imam Reza Street, Dental School, Shahid Sadoughi University of medical science, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Fax
+98 35 3726 3733
Email
hosseinaghily@gmail.com
2
Recruitment center
Name of recruitment center
Department of Orthodontics, School of Dentistry, Shahid Sadoughi University of Medical Sciences, Yaz
Full name of responsible person
Hossein Agha Aghili
Street address
Dahe Fajr Boulevard, Imam Reza Street, Dental School, Shahid Sadoughi University of medical science, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3824 1785
Fax
+98 35 3726 3733
Email
fariba.zadbin.1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi
Street address
Bahonar Square, Shahid Sadoughi University of medical science, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3726 3733
Fax
+98 35 3726 3733
Email
dvc.research@ssu.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Dahe Fajr Boulevard.Imam Reza Street.Shahid Sadoughi University of medical science.Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3824 1785
Email
fariba.zadbin.1373@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After deidentifying people, matrix metalloproteinase-1 values in both treatment and control groups can be shared.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions and valid scientific research journals
Under which criteria data/document could be used
In order to use the documents of this study for other studies and researches to apply the results
From where data/document is obtainable
Responsible person in this field: Fariba Zadbin , email address: fariba.zadbin.1373@gmail.com
What processes are involved for a request to access data/document
The applicant can send his request to the above-mentioned email address with his introduction and the reason for the request and receive the information as soon as possible (finally within 7-10 days).