Objective: Determine the antibacterial effectiveness of root canal irrigator in primary endodontic infection
Design: Determine and comparison of the count of Enterococcus faecalis and Fusobacterium nucleatum before and after irrigation with sodium hypochlorite 5.25%, hypoclean, chlorhexidine 2% and chlorhexidine plus in primary endodontic infection.
Setting and conduct: 40 consented patients who are referred to the endodontic department of Tehran university of medical sciences with primary endodontic infection in single rooted premolar will participate in this study. Patients are divided into 4 groups randomly and in each group one of the irrigators will be used. After sterilization, We'll sampling of intracanal before and after irrigation. The number of bacteria in all samples will be determined by use of molecular methods. Collected data will be analyzed by using statistical methods (T-test).
Inclusion criteria: Premolar teeth with single root and the single canal; Necrotic teeth confirmed with no response to cold test; Tooth that is sensitive to percussion and palpation
Exclusion criteria: History of antibiotic therapy in last 3 months; Systemic disease; Tooth that is unable to isolate with rubber dam; Periodontal pocket more than 4 mm
Intervention: root canal irrigation by 5 milli litre of one of irrigators in each group (sodium hypochlorite 5.25% in first group, hypoclean in second group, chlorhexidine 2% in third group, chlorhexidine plus in fourth group) for 20 min during root canal therapy
Main outcome measures: the count of Enterococcus faecalis and Fusobacterium nucleatum
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111530899N1
Registration date:2017-02-08, 1395/11/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-08, 1395/11/20
Registrant information
Name
Sedigheh Khedmat
Name of organization / entity
Tehran University of Medical Sciences, Faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2721
Email address
khedmats@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antibacterial power of different irrigation solutions (sodium hypochlorite, hypoclean, CHX, CHX pluse) in primary endodontic infection: clinical trial
Public title
Comparison of Antibacterial effect of intra canal irrigators (sodium hypochlorite, hypoclean, CHX and CHX pluse) in teeth with primary endodontic infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Premolar teeth with single root and single canal; Necrotic teeth confirmed with no response to cold test; Tooth that is sensitive to percussion and palpation
Exclusion criteria: History of antibiotic therapy in last 3 months; Systemic disease; Tooth that is unable to isolation with rubber dam; Periodontal pocket more than 4 mm
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized with close packets
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran university of medical science
City
Tehran
Postal code
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1232
Health conditions studied
1
Description of health condition studied
Primary endodontic infection
ICD-10 code
K04.1
ICD-10 code description
Necrosis of pulp
Primary outcomes
1
Description
Number of enterococcus faecalis
Timepoint
Before and after canal irrigation within 20 min
Method of measurement
Real time PCR
2
Description
Number of fusobacterium nucleatum
Timepoint
Before and after canal irrigation within 20 min
Method of measurement
Realtime PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: root canal irrigation by 5 milliliter sodium hypochlorite 5.25% (ERKAMED. MEDICAL COMPANY) for 20 min during root canal therapy
Category
Other
2
Description
Intervention group: root canal irrigation with 5 milliliter chlorhexidine 2% (ERKAMED. MEDICAL COMPANY) for 20 min during root canal therapy
Category
Other
3
Description
Intervention group: root canal irrigation with 5 milliliter Hypoclean (Ogna Laboratori Farmaceutici, Milano, Italy) for 20 min during root canal therapy
Category
Other
4
Description
Intervention group: root canal irrigation with 5 milliliter CHX-Plus (Vista Dental Products, Racine, WI) for 20 min during root canal therapy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic department, Faculty of dentistry, Tehran university of medical science
Full name of responsible person
Nooshin Fakhari
Street address
Tehran dental school, North kargar street, Tehran
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
Mohammad sadegh Ahmadakhondi
Street address
Dental school, North Kargar street, Tehran
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
Tehran University of Medical Sciences Faculty of Dentistry
Full name of responsible person
Nooshin Fakhari
Position
Resident of endodontic department
Other areas of specialty/work
Street address
Dental school, North Kargar street, Tehran
City
Tehran
Postal code
1417614411
Phone
+98 21 8835 1173
Fax
---------------
Email
nooshin_67@ymail.com
Web page address
--------------
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science Faculty of Dentistr
Full name of responsible person
Dr. Sedighe Khedmat
Position
Full professor
Other areas of specialty/work
Street address
Tehran dental school, north kargar street, Tehran
City
Tehran
Postal code
1417614411
Phone
+98 21 8849 7389
Fax
--------------
Email
s_khdmt@yahoo.com
Web page address
------------------
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science Faculty of Dentistry
Full name of responsible person
Nooshin Fakhari
Position
Resident of Endodontic Department
Other areas of specialty/work
Street address
Dental school, North Kargar street, Tehran
City
Tehran
Postal code
1417614411
Phone
+98 21 8835 1173
Fax
-----------------
Email
nooshin_67@ymail.com
Web page address
--------------
Sharing plan
Deidentified Individual Participant Data Set (IPD)