Comparison of the effect of the use of the two types of Nd: YAG 1064 nm laser) (Er: YAG (2940 nm) on thermal changes of the premolars human pulp during removal of ceramic brackets (clinical trial)
Determine the mean pulp temperature before and after laser irradiation in the studied groups
Design
The clinical trial included two arm parallel groups,consisting of 24 samples, randomized, double-blind, and randomized by www.random.org
Settings and conduct
The study was conducted as a clinical trial with random sampling at the Faculty of Dentistry of Islamic Azad University.The study is double blinded and the evaluator and investigator are blind.
Participants/Inclusion and exclusion criteria
All the patients were in good health as determined by health history and verbal questions . All the participants are not allowed to take any kind of medications . Teeth included should not have any kind of restorations, caries, hypocalcification and cracks . Teeth should have normal reaction to cold test.Teeth should not be loose or have swelling in the soft tissue around . The radiographic findings of these teeth should be free from damage in PDL and the area around the root.If any of the above items does not exist, patients will not be allowed to go to study.
Intervention groups
In the first group,.an Er: YAG laser will be used at 2940 nm wavelength lightweakter (LightWalker AT, Fotona, Ljubljana, Slovenia).
In the second group, an Nd: YAG laser with a wavelength of 1064 nm will be used the LightWalker (LightWalker AT, Fotona, Ljubljana, Slovenia)
Main outcome variables
temperature changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110212005804N4
Registration date:2019-10-15, 1398/07/23
Registration timing:retrospective
Last update:2019-10-15, 1398/07/23
Update count:0
Registration date
2019-10-15, 1398/07/23
Registrant information
Name
Mahta Fazlyab
Name of organization / entity
Islamic Azad University, Dental Branch, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
mfazlyab@dentiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-01, 1397/11/12
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of the use of the two types of Nd: YAG 1064 nm laser) (Er: YAG (2940 nm) on thermal changes of the premolars human pulp during removal of ceramic brackets (clinical trial)
Public title
effect of laser on the pulp changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients were in good health as determined by health history and verbal questioning.
All the participants are not allowed to take any kind of medications.
Teeth included in this study should not have any kind of restoration ,caries , hypocalcification or cracks.
Teeth should have normal reaction to cold test and this reaction will compare to the same tooth in the other quadrant.
Teeth should not be loose or have swelling in the soft tissue around and be sensitive to the percussion and palpation.
the radiographic findings of these teeth should be free from damage in PDL and the area around the root.
Exclusion criteria:
Patients with systemic problems modifying the treatment process and taking all kinds of systemic drugs will not be included in the study.
The teeth with cracks ,restorations ,caries and hypocalcification will not be included in the study.
If the tooth in the radiographic clinical examination shows the sign of any radicular lesion, it will be excluded.
The patient's sensitivity to cold, heat, or chewing pressure on the teeth that causes the teeth to fail to enter the study.
Age
From 12 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
6
More than 1 sample in each individual
Number of samples in each individual:
4
The samples consisted of four first or second premolar teeth in one jaw between 12 and 30 years old who needed to remove these teeth for orthodontic treatment plan.
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are placed in a randomized 4-block by the method of Balanced Block. The randomization process is performed by an individual other than the investigator, and information about the sample intervention is stored in sealed envelopes in order to randomize the excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is aware of the research process.
The analyzer is not aware of the investigation process.
The evaluator is not aware of the research process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Dentistry, Islamic Azad University
Street address
No. 9,Faculty of Dentistry Islamic Azad University,9th neyestan Ave,Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.029
Health conditions studied
1
Description of health condition studied
pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
temperature changes
Timepoint
The temperature immediately after laser irradiation and removal of the bracket (TL) will be measured and recorded by the thermometer (Hanyoungnux, series, D55, Korea). The temperature will then be recorded in the intervals of one minute for 10 minutes (TL1 to TL10).
Method of measurement
Immediately after the cavity is prepared, the temperature of the pulp will be measured (Taccess). Then, the temperature changes will be recorded as T1 to T10 for up to 10 minutes at 1 minute intervals. The temperature test was continued up to 2 minutes after the temperature was stabilized to ensure temperature stability and then the data were evaluated before the onset of the main treatment and recorded as the initial temperature before the radiation (TBase). After laser irradiation and debonding the brackets, the temperature will be measured immediately (T laser), and then the temperature will be recorded as TL1 to TL10 for up to 1 minute intervals.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the first group,. An Er: YAG laser will be used at 2940 nm wavelength lightweakter (LightWalker AT, Fotona, Ljubljana, Slovenia). The handpiece will be used for contact type (H14 C, Fotona, Slovenia). The fiber used is Cylinderry and its tip, with a length of 8 mm and a diameter of 3.1 mm. The settings for this mounting bracket are as follows: 1.2 W, 600 MJ, 2 Hz, Pulse Long without spray of weather
Category
Treatment - Devices
2
Description
Second invertion group:In the second group, a Nd: YAG laser with a wavelength of 1064 nm will use the LightWalker AT, Fotona, Ljubljana, Slovenia, which has the characteristics as follows: 0.2 millisecond pulses and 3 watts for 3 seconds The outer diameter of the fiber is 400 microns and its tip is 1 mm from the surface of the bracket and perpendicular to the bracket surface. After the prescribed period of radiation, the bracket device is removed with the plug-in.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry of Islamic Azad university
Full name of responsible person
Dr Mahta Fazlyab
Street address
No. 9,Faculty of dentistry of Islamic Azad university,9th Neyestan Ave,Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
+98 21 2256 4577
Email
dr.mfazlyab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi (Vice chancellor of research, Islamic Azad University of medical scinces)
Street address
No. 9, 9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor of research, Islamic Azad University of medical scinces
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr Mahta Fazlyab
Position
Assistant Professor of Endodontics department, Faculty of Dentistry of Islamic Azad University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mahta Fazlyab
Position
Assistant Professor of Endodontics Department,Faculty of Dentistry of Islamic Azad University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9,9th Neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.mfazlyab@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahta Fazlyab
Position
Assistant Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
number 4, 10th Neyestan, Pasdaran st
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2275 2019
Fax
+98 21 2205 5386
Email
dr.mfazlyab@gmail.com
Web page address
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as the key outcome information or the like, can share.
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
Readers of the published article
Under which criteria data/document could be used
In case of publish the article
From where data/document is obtainable
Target journal
What processes are involved for a request to access data/document