comparison of the effect of the use of the two types of laser Nd:YAG(1064nm) and Er:YAG(2940nm) on histologic changes of the premolars human pulp during removal of ceramic brackets (clinical trial)
Comparing the Nd: YAG and Er: YAG lasers for ceramic brackets debonding on histological changes of pulp in human premolars
Design
Randomized single-blind clinical trial on two study groups consisting of 36 samples that allocate into random blocks using balanced block technique
Settings and conduct
The study is carried out in the Faculty of Dentistry of Islamic Azad University. The brackets are debonded from the teeth by laser and immediately extracted. And teeth are fixed in 10% formalin solution. The specimens are prepared according to the ISO7405 standard and prepared by a pathologist examiner after providing along the longitudinal axis and staining. According to this standard, grade 0, refers to samples without inflammation, grade 1; to mild inflammation, grade 2; to moderate inflammation, grade 3; to severe inflammation and grade 4 to abscess formation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with two premolar teeth in one jaw that need extraction for orthodontic treatment.
Exclusion criteria: Patients with systemic conditions modifying the treatment and taking any systemic medicine, teeth with cracks, restorations, caries and hypocalcification, any sign of radicular lesion in radiographic examination, or tooth sensitivity to cold, heat or bite pressure.
Intervention groups
First intervention group: Er: YAG laser with 2940 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface.
In the second group : Nd: YAG laser with 1064 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface.
Main outcome variables
histologic changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110212005804N6
Registration date:2019-12-21, 1398/09/30
Registration timing:retrospective
Last update:2019-12-21, 1398/09/30
Update count:0
Registration date
2019-12-21, 1398/09/30
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
2019-04-10, 1398/01/21
Actual recruitment end date
2019-11-19, 1398/08/28
Trial completion date
2019-11-19, 1398/08/28
Scientific title
comparison of the effect of the use of the two types of laser Nd:YAG(1064nm) and Er:YAG(2940nm) on histologic changes of the premolars human pulp during removal of ceramic brackets (clinical trial)
Public title
effect of laser on pulp histology
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with at least two premolar teeth in a single jaw that need to be extracted for orthodontic treatment.
Exclusion criteria:
Patients with systemic problems that modify the treatment procedure
Patients taking any systemic medicine
Teeth with cracks, existing restorations, caries and hypocalcification.
Any radicular lesion in clinical or radiographic examination
The tooth sensitivity to cold, heat, or bite pressure on the teeth
Age
From 12 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
28
More than 1 sample in each individual
Number of samples in each individual:
2
Samples include one premolar tooth on the left and one premolar on the right side of one jaw. A total of 28 patients will be included providing 28 pairs of teeth (totally 56 samples) for each intervention group.
Actual sample size reached:
28
More than 1 sample in each individual
Actual sample size in each individual:
2
Samples included one premolar tooth on the left and one premolar on the right side of one jaw. A total of 28 patients were included providing 28 pairs of teeth (totally 56 samples) for each intervention group.
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly allocated to double blocks using random-block technique. Random allocation will be done using Excel software by a blinded person who is not among the investigators and the intervention details will be kept in sealed and coded pockets. As a result patient allocation will be done based on age and gender. The pockets have 28 numbers for the first intervention groups and 28 numbers for the second intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluation process is done by someone other than the practitioner who does the operation. He does not have access to patient's information, either. Moreover, histological evaluation is done in the absence of patient and the practitioner.
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.1397.030
Health conditions studied
1
Description of health condition studied
pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
histologic changes
Timepoint
Immediately after laser irradiation and bracket debonding the teeth are extracted and sent for preparation and histological evaluation.
Method of measurement
َThe specimens will be evaluated according to ISO7405 standard.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Er: YAG laser with 2940 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The parameters are based on device pre-sets as follows: 1.2 W, 600 MJ, 2 Hz, lung pulse without air spray. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface. After radiation, the bracket is removed with a plugger.
Category
Treatment - Devices
2
Description
Second invertion group: Nd: YAG laser with 1064 nm wavelength (Fotona, Slovenia) will be used for bracket debonding. The parameters are based on device pre-sets as follows: pulse length 0.2 millisecond and energy 3 watts for 3 seconds. The irradiation will last for 3 seconds and the beam is parallel to tooth surface and in the tooth-bracket interface. After radiation, the bracket is removed with a plugger.
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
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
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, 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
No.9, 9th neyestan Ave, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2275 2019
Fax
+98 21 2205 5386
Email
dr.mfazlyab@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
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
Researchers and college students who are involved in the treatment of patients in common can use data
Under which criteria data/document could be used
All the clinicians who use laser to debond ceramic brackets can access the documents using the following address.
dr.Mahta Fazlyab
dr.mfazlyab@yahoo.com
Faculty of dentistry of Islamic Azad university
+982122564571
No. 9,Faculty of dentistry of Islamic Azad university,9th Neyestan Ave,Pasdaran Ave
From where data/document is obtainable
Applicants can contact the person responsible for the article to receive the information.
dr.Mahta Fazlyab
dr.mfazlyab@yahoo.com
Faculty of dentistry of Islamic Azad university
+982122564571
No. 9,Faculty of dentistry of Islamic Azad university,9th Neyestan Ave,Pasdaran Ave
What processes are involved for a request to access data/document
Demand by email to the person responsible for the article
dr.Mahta Fazlyab
dr.mfazlyab@yahoo.com