A comparison of effect of photodynamictherapy with LED and Calcium Hydroxide therapy on root canal disinfection in patienst's treated teeth and periapical lesion
Objectives: Comparison of antibacterial effect of intracanal calcium hydroxide and photodynamic therapy by LED against E.faecalis after retreatment in patients’ teeth with periapical lesions
Design, Setting and conduct: Study population involves 2 of 10 person group of patient presenting to endodontic department (just one center) with molars that their root canal therapies failed, and have periapical lesions (major eligibility criteria). Patients will be allocated to the groups according to computer generated random number table.
After chemomechanichal cleaning, blind practitioner carries out the first sampling by sterile rotary file. Then group 1 (n=10) goes under the photodynamic therapy (first intervention) and group 2, calcium Hydroxide therapy for 2 weeks (intervention 2). The second samples will be obtained from both groups.
First and second samples cultured on specific culturing environment of E.faecalis and the results of colony counting reported as CFUs (primary outcome variables). If the result of each fist sample culturing be negative, the sample would be excluded (major exclusion criteria). Then the results will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092624206N1
Registration date:2016-06-18, 1395/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Afsaneh Rahmati
Name of organization / entity
Shahid Beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 22403075
Email address
a.rahmati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Laser application in medical science research center,Shahid Beheshti University of Medical Science,Tehran,Iran
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of effect of photodynamictherapy with LED and Calcium Hydroxide therapy on root canal disinfection in patienst's treated teeth and periapical lesion
Public title
A comparison of effect of photodynamictherapy with LED and calcium hydroxide therapy on root canal disinfection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Visible PA lesion must be presented
2- No clinical symptoms
3- no systemic disease
exclusion criteria:
1- negative culture of E.faecalis befor PDT or Ca(OH)2 therapy
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
allocation to groups according to computer generated random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science,Laser Application in Medical Scien
Street address
Shohadaye Tajrish hospital,Tajrish square
City
Tehran
Postal code
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SBMU.REC.1394.176
Health conditions studied
1
Description of health condition studied
Root canal infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
CFU counting of E.faecalis
Timepoint
before and after treatments
Method of measurement
inspection with colony counter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: photodynamictherapy with LED FotOSan ( MDD, CMS Dental Denmark Korea) 200 mW/cm2
wave lenght: 630 nm for 60 s
photpsensitizer: toloeiden blue 15 ugr/ml for 5 min
Category
Treatment - Other
2
Description
Intervention group 2: putting intracanal calcium hydroxide paste for 2weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic department,school of dentistry,Shahid Beheshti University of Medical Science
Full name of responsible person
Mohammad Asnaashari
Street address
Faculty of dentistry,Shahid Beheshti University of Medical Science, Daneshjoo Boulevard,Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Laser application in medical science research center,Shahid Beheshti University of Medical Science
Full name of responsible person
Mohammad Reza Razzaghi
Street address
Shohadaye Tajrish hospital,Tajrish square
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 science 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
Shahid Beheshti University of Medical Science
Full name of responsible person
Afsaneh Rahmati
Position
Resident of Endodontics
Other areas of specialty/work
Street address
Evin, Daneshjoo boulevard
City
Tehran
Postal code
Phone
+98 21 2614 2964
Fax
Email
drrahmati@@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti university of medical science
Full name of responsible person
Mohammad asnaashari
Position
Professor
Other areas of specialty/work
Street address
Daneshjoo boulevard,Evin
City
Tehran
Postal code
Phone
+98 22749221
Fax
Email
mo_asna@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Science
Full name of responsible person
Afsaneh Rahmati
Position
Resident of Endodontics
Other areas of specialty/work
Street address
Daneshjoo boulevard, Evin
City
Tehran
Postal code
Phone
+98 21 2614 2964
Fax
Email
drrahmati@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)