Protocol summary

Summary
Background and Objectives: This study aimed to compare the antimicrobial efficacy of calcium hydroxide (CH) as a intracanal medication and photodynamic therapy (PDT) against E.faecalis and Candida albicans in teeth with periapical (PA) lesions. Methods: this in-vivo study was conducted on twenty patients with single-rooted mandibular premolar with previously failed endodontic treatment. After the conventional chemo-mechanical root canal preparation (hand and rotary instruments and 2.5% NaOCL), microbiological samples were obtained using sterile paper points, stored in thioglycolate solution and transferred to a microbiology laboratory. Group 1 (n=10) specimens underwent PDT(diode laser 810 nm+50 mg/ml methylene blue) and Creamy CH paste was used in group 2 for one week. A second sample was taken with sterile paper points. The samples were dispersed in transport medium, serially diluted, and cultured on selective mediums (Bile esculinazide agar for E.faecals and Sabouraud dextrose agar for candida albicans) to determine the number of colony forming units (CFU).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016090429686N1
Registration date: 2016-11-29, 1395/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-29, 1395/09/09
Registrant information
Name
Mohammad Asnaashari
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5350
Email address
m-asnaashari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The laser application in medical sciences research center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2014-05-01, 1393/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Antimicrobial Efficacy of Calcium Hydroxide and Photodynamic Therapy against Enterococcus faecalis and candida albicans in Teeth with Periapical Lesions; an in vivo study
Public title
Antimicrobial efficacy of calcium hydroxide and photodynamic therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Iinclusion criteria were optimal general health and having a mandibular premolar with a PA lesion on the primary radiograph two years after its primary endodontic treatment. Patients with broken tooth, ledge, over-filling, transportation, root resorption or perforation were excluded.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
universal trial number
Secondary trial Id
U1111-1188-0043
Registration date
2016-09-26, 1395/07/05

Ethics committees

1

Ethics committee
Name of ethics committee
Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Science
Street address
Shohada Tajrish hospital, Tajrish Sq., Tehran, Iran
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.SBMU.REC.1392.320

Health conditions studied

1

Description of health condition studied
Teeth with Periapical Lesions
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intera canal microbial load
Timepoint
One week
Method of measurement
CFU/ml

Secondary outcomes

empty

Intervention groups

1

Description
The effect of calcium hydroxide therapy on the experimental group
Category
Treatment - Drugs

2

Description
The effect of low level laser treatment on groups
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Endodontic Department, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Science
Full name of responsible person
Ms Razzaghi
Street address
Shohada Tajrish hospital, Tajrish Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Science
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
Endodontic Department, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mojtahedbidabadi
Position
Assistant professor
Other areas of specialty/work
Street address
Endodontic Department, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Velenjak St., Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2217 5350
Fax
Email
maryam.mojtahed@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endodontic Department, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Asnaashari
Position
Professor
Other areas of specialty/work
Street address
Endodontic Department, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Velenjak St., Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2217 5350
Fax
Email
m-asnaashari@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Endodontic Department, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Mojtahedbidabadi
Position
Assistant professor
Other areas of specialty/work
Street address
Endodontic Department, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Velenjak St., Chamran Highway
City
Tehran
Postal code
Phone
+98 21 2217 5350
Fax
Email
maryam.mojtahed@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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