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The effect comparison of the diode laser 940 nm and triple antibiotic on Minocycline resistance genes (Tet M , Tet W , Tet L ) in Enterococcus faecalis isolated from primary root canal infections

Protocol summary

Study aim
The effect comparison of the diode laser 940 nm and triple antibiotic on Minocycline resistance genes (Tet M , Tet W , Tet L ) 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
Patients with necrotic teeth are included in the study after confirmation by vitality tests. Initial sampling is performed before entering the root canal,After this stage, patients are divided into three groups: the first group received laser treatment, the second group received laser and triple therapy and the third group received the triple therapy.. After these interventions, a secondary sampling is performed, sampling procedure is carried out at the Zahedan Dental School and is performed by a endodontist. Then samples are sent to the lab for microbiological evaluations.
Participants/Inclusion and exclusion criteria
The patient have no systemic disease and have not taken antibiotics within the last 3 months. Pregnant women, patients with active periodontal disease, and patients with non-isolated or open apex are excluded from the study.
Intervention groups
Group 1; Laser intervention: With 2W power and continuously used in the root canal. Group 2; Medication and Laser intervention: First, laser is shoot,then the triple antibiotic will be dress in the root canal. Group 3; Medication intervention: Triple antibiotics enter the root canal with Lentulo
Main outcome variables
Changing the number of intracanal bacteria (e.g. Enterococcus faecalis), Investigating the presence of minocyclin resistant gene in Enterococcus faecalis,Examine the gene expression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170715035087N1
Registration date: 2018-04-07, 1397/01/18
Registration timing: prospective

Last update: 2018-04-07, 1397/01/18
Update count: 0
Registration date
2018-04-07, 1397/01/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 9482
Email address
foroughfarahi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-05-10, 1397/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect comparison of the diode laser 940 nm and triple antibiotic on Minocycline resistance genes (Tet M , Tet W , Tet L ) in Enterococcus faecalis isolated from primary root canal infections
Public title
The effect of laser for the therapy of microbial infection in the root of teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with age ranges from 15 to 60 years who visit the Department of Endodontics at the Faculty of Dentistry in Zahedan, and are diagnosed as "necrotic pulp" with and without periapical involvement after having performed the vitality test The patients whose teeth are closed apex, with no connection between canal pulp and oral cavity The patients with no medical records in endodontic treatment, root resorption, calcification, and periodontal pocket with the depth at least 5 mm. The patients who have not been hospitalized within last three months and have not consumed antibiotics
Exclusion criteria:
The observation of necrotic pulp after entering the pulp chamber and root canal, or due to the traumatic necrosis The inability to isolate the tooth which results in the contamination of the treatment environment by saliva Pregnancy Patients who remember taking antibiotics during treatment The patient's disinterest in participating in the study
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
patients was randomly assigned to 1 of the 3 designated groups. Randomization was developed to eliminate any bias on the part of the investigators and to balance the number of patients between the treatment protocol types. Using an equal proportion randomization allocation ratio, 1 of the investigators (A.G.) created envelopes that contained concealed assignment codes that were assigned sequentially to eligible patients. It was ensured that neither the primary investigator nor the patient was aware of the treatment protocol
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
Ethics committee of Zahedan university of medical sciences
Street address
Dr Hesabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816864997
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.ZAUMS.REC.1396.191

Health conditions studied

1

Description of health condition studied
Infection of root canal system
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases

Primary outcomes

1

Description
Number of bacteria in the root canal
Timepoint
before intervention, after intervention
Method of measurement
real time PCR

2

Description
Investigation and expression of minocyclin resistant genes in Enterococcus faecalis
Timepoint
before intervention, after intervention
Method of measurement
PCR

Secondary outcomes

empty

Intervention groups

1

Description
Laser therapy with a 2-watt diode laser(EPIC X ,BIOLASE,Irvine,CA 92618, USA) is used continuously and for each canal three times in one session.laser tip(EZTIP400&300)
Category
Treatment - Drugs

2

Description
laser and medication: First, laser diode (EPIC X ,BIOLASE,Irvine,CA 92618, USA)is shoot,The laser tip enters Only in the first session, three times,in root canal then the triple antibiotic will be dress in the root canal for a week.Triple antibiotic paste using the ratio: two tablets of metronidazole 250mg (Tehran chemie), two ciprofloxacin 250 mg tablets (Daroupakhsh-Tehran-Iran) and 5 tablets of minocycline 100 mg (Iran darou) to achieve a 1: 1: 1 ratio , Combined)
Category
Treatment - Drugs

3

Description
Control group: triple antibiotic;Triple antibiotic paste using the ratio: two tablets of metronidazole 250mg (Tehran chemie), two ciprofloxacin 250 mg tablets (Daroupakhsh-Tehran-Iran) and 5 tablets of minocycline 100 mg (Iran darou) to achieve a 1: 1: 1 ratio , Combined) The drug enters the canal with Lentulo, it remains within the root canal For a week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan Dental School
Full name of responsible person
Forough Farahi
Street address
School of Dentistry,East Azadegan Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816864997
Phone
+98 54 3342 3141
Email
foroughfarahi@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Deputy of Research of Zahedan University of Medical Sciences
Street address
School of Dentistry,East Azadegan Street, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816864997
Phone
+98 54 3342 3141
Email
f_farahi67@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Forough Farahi
Position
Endodontics resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry,East Azadegan Street, Zahedan,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816864997
Phone
+98 54 3342 3141
Email
f_farahi67@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Eshaghali saberi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Azadegan Street, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
saberiendo@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Forough Farahi
Position
Resident of Endodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry,East Azadegan Street, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816864997
Phone
+98 54 3342 3141
Email
f_farahi67@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
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 including the counting of bacteria and the prevalence of faecalis in the root canal and the occurrence of antibiotic resistance genes could 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 scientific institutions
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
To the corresponding author
What processes are involved for a request to access data/document
Administrative correspondence through the deputy of research and technology
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