comparison effect of diode laser 940 nm and triple antibiotic on Minocycline resistance genes(Tet Q , Tet S , Tet O ) in Enterococcus faecalis isolated from primary root canal infections
comparison effect of diode laser 940 nm and triple antibiotic on Minocycline resistance genes(Tet Q , Tet S , Tet O ) in Enterococcus faecalis isolated from primary root canal infections
Design
In this study,patients with 150 necrotic pulp with the inclusion criteria for entering the study are selected and sample will be taken at the endodontics department of Zahedan dental school. An unpredictable sampling will be done, so that the root canal sampling is done by a specialist in the dental clinic.
Settings and conduct
In this study, 150 necrotic pulp was selected. Sampling will done at the endodontics department of Zahedan dental school. patients are divided into three groups
Participants/Inclusion and exclusion criteria
inclusion critria:Patients aged 15-60 years who referred to the endodontic department of Zahedan dental school, and after having performed vitality test, the diagnosis of "necrotic pulp" with and without periapical involvement was done for their teeth; dental pulp in relation to the cavity Mouth; the patient has not been admitted to the hospital for the last three months and has not taken antibiotics; The tooth has not been treated with endodontic treatment.
exclusion criteria:The absence of necrotic pulp after entering the chamomile pulp and root canal; the impossibility of tooth isolation and the contamination of the saliva treatment environment; Patients who remember the use of misleading drugs
Intervention groups
group1:laser, group2:laser medication, group control:medication
Main outcome variables
changing intracanal bacteria count, Report on the prevalence of Enterococcus faecalis in the root canal, Investigation of Myocyelucline Antibiotic Resistance Genes in Enterococcus faecalis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170712035051N2
Registration date:2018-03-11, 1396/12/20
Registration timing:registered_while_recruiting
Last update:2018-03-11, 1396/12/20
Update count:0
Registration date
2018-03-11, 1396/12/20
Registrant information
Name
shima bijari
Name of organization / entity
zahedan university medical science
Country
Iran (Islamic Republic of)
Phone
+98 915 362 4457
Email address
shima.bijari@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison effect of diode laser 940 nm and triple antibiotic on Minocycline resistance genes(Tet Q , Tet S , Tet O ) in Enterococcus faecalis isolated from primary root canal infections
Public title
The effect of laser in the treatment of microbial infection of the root of the tooth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients aged15-60 years old who referred to the Department of Endodontics at the Faculty of Dentistry in Zahedan And after having performed a vitality test, the diagnosis of "necrotic pulp. three months and has not taken antibiotics.
"Dental pulp is not related to the oral cavity
The patient has not been hospitalized for the past three months and has not taken antibiotics.
The tooth has not been treated with endodontic treatment.
Exclusion criteria:
Exclusion criteria: The absence of necrotic pulp after entering the chamber pulp and root canal the impossibility of tooth isolation and the contamination of the operating environment with saliva patients who remember the course of treatment of confusing drugs
Age
From 78 years old to 51 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: For simple randomization of 150 numbered records, the type of intervention is specified by the individual, and the files will be removed accordingly
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
zahedan university of medical sciences
Street address
zahedan-Dr Hasabi's Square-
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.ZAUMS.REC.1396.192
2
Ethics committee
Name of ethics committee
zahedan university of medical sciences
Street address
zahedan-Dr Hasabi's Square-
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.ZAUMS.REC.1396.192
Health conditions studied
1
Description of health condition studied
Infection of root canal system
ICD-10 code
B99-B99
ICD-10 code description
سایر بیماری های عفونی
Primary outcomes
1
Description
Expression of a gene resistant to triple antibiotics
Timepoint
before intervention-1 week after intervention
Method of measurement
polymerase chain reaction
2
Description
reduction colony count
Timepoint
before intervention-1 week after intervention
Method of measurement
number colony count
Secondary outcomes
empty
Intervention groups
1
Description
group 1: intervention with laser
Category
Treatment - Drugs
2
Description
Intervention group2: intervention with laser and triple antibiotic
Category
Treatment - Drugs
3
Description
Control group:triple antibiotic
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan dental school
Full name of responsible person
Shima Bijari
Street address
department of endodontics،dental school،east azadegan street،zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
shima.bijari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
the university of zahedan
Full name of responsible person
deputy of research of zahedan university of medical sciencess
Street address
zahedan-azadegan street-dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
shima.bijari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
the university of zahedan
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
The university medical school of zahedan
Full name of responsible person
Shima bijari
Position
Endodontics resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
East azadegan street,zahdan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Fax
Email
shima.bijari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university medical school of zahedan
Full name of responsible person
Eshaghali saberi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East azadegan street-dental school zadedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Fax
Email
saberiendo@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The university medical school of zahedan
Full name of responsible person
Shima bijari
Position
Resident of endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
East azadegan street,zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Fax
Email
shima.bijari@yahoo.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
No - There is not 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
Part of the individual data and information with the outcomes include the counting of bacteria and the prevalence of faecalis in the root canal and the occurrence of antibiotic resistance genes that can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
In order to replicate scientific studies and development, data can be used
From where data/document is obtainable
Author of the article
What processes are involved for a request to access data/document
Administrative correspondence through the deputy of research and technology