Determination of bacterial agents involved in root canal of patients with endodontic infection and evaluation of effect of photo-activated disinfection (PAD) on reduction of bacterial population
The aim of this study is the determination of bacterial agents involved in endodontic infection by using Multiplex Real Time PCR on clinical specimens and culture before and after the effect of PAD. The confirmation of endodontic disease in the canine teeth of patient by dentist is inclusion criteria and having a sharp curve observed in X-rays in root canal is exclusion criteria. Sampling is done from the single-channel tooth pulp of 50 patients with endodontic infections. Following the identification of bacterial agents, the impact of indocyanine green is evaluated on expression of at least two virulence factors of resistant bacterial species to PAD by RT-PCR.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031321455N1
Registration date:2015-08-06, 1394/05/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Abbas Bahador
Name of organization / entity
Tehran Universiyt of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5810
Email address
m-pourhajibagher@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Funding for the project is the responsibility of the School of Medicine, Tehran University of Medical Sciences.
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of bacterial agents involved in root canal of patients with endodontic infection and evaluation of effect of photo-activated disinfection (PAD) on reduction of bacterial population
Public title
Effect of laser on reduction of bacterial agents involved in root canal infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patient did not receive antibiotics for at least a month; The patient is not used immunosuppressive drugs; The patient has not systemic disease; The dentist is confirmed endodontic disease in his canine teeth (according abscess, radiography and ...).
Exclusion criteria: The patient's age should not be less than 18 years (due to lack of complete form of APEX) and not be more than 50 years (due to be necrotic pulp); There is a sharp curve in root canal in radiography findings.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethical committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina Ave., Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
14167-53955
Approval date
2015-04-26, 1394/02/06
Ethics committee reference number
tums.rec 27681
Health conditions studied
1
Description of health condition studied
Endodontic infection
ICD-10 code
XXII
ICD-10 code description
Codes for special purposes
Primary outcomes
1
Description
Growth of bacteria
Timepoint
Before and after of interferer
Method of measurement
Culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Indocyanine green as photosensitizer with concentrations of 500 and 1000 ug/L
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry College
Full name of responsible person
Dr. Nasim Chiniforoush
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Unesian
Street address
Tehran University of Medical Sciences, Poursina Ave., Keshavarz Blvd, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Maryam Pourhajibagher
Position
PhD Student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina Ave., Keshavarz Blvd, Tehran, Iran