Antibacterial effect of sodium hypochlorite 6% plus chlorhexidine 0.2% and calcium hydroxide powder versus sodium hypochlorite 6% alone on the endodontic lesion in patients with apical periodontitis: a double blind randomized clinical trial
Objectives: To assess the antibacterial effect of sodium hypochlorite 6% plus chlorhexidine 0.2% and calcium hydroxide powder versus sodium hypochlorite 6% alone on endodontic lesion
Design: a double blind, randomized clinical trial.
Setting and conduct: The eligible patients with single-rooted tooth with pulp necrosis and apical periodontitis who will refer to Dentistry School during the study period will be enrolled into the trial.
Inclusion criteria: (a) having single-rooted tooth with pulp necrosis and apical periodontitis; (b) having a negative response to pulp test; (c) presence of radiographic lesion.
Exclusion criteria: (a) receiving antibiotic during the last three months; (b) extensive decay or fracture of the crown or root; (c) tooth with previous root canal repair; (d) teeth with probing more than 4 mm in depth.
Intervention: Irrigation of root canal with 10 ml sodium hypochlorite 6% plus chlorhexidine 0.2% and calcium hydroxide powder.
Control: Irrigation of root canal with 10 ml sodium hypochlorite 6%.
Primary outcome: Evaluation of Enterococcus faecalis colonization 2 weeks after treatment using bacterial counts
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502169014N55
Registration date:2015-02-23, 1393/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-09-13, 1393/06/22
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antibacterial effect of sodium hypochlorite 6% plus chlorhexidine 0.2% and calcium hydroxide powder versus sodium hypochlorite 6% alone on the endodontic lesion in patients with apical periodontitis: a double blind randomized clinical trial
Public title
Antibacterial effect of sodium hypochlorite 6% plus chlorhexidine 0.2% and calcium hydroxide powder versus sodium hypochlorite 6% alone on the endodontic lesion in patients with apical periodontitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) having single-rooted tooth with pulp necrosis and apical periodontitis; (b) having a negative response to pulp test; (c) presence of radiographic lesion.
Exclusion criteria: (a) receiving antibiotic during the last three months; (b) extensive decay or fracture of the crown or root; (c) tooth with previous root canal repair; (d) teeth with probing more than 4 mm in depth.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: random assignment of the patients systematically one at a time to intervention and control groups.
Blinding: Patients will not be aware of the type of treatment they receive. The examiner who will examine the patients is another person that will not be aware of the type of intervention. Therefore, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2015-02-15, 1393/11/26
Ethics committee reference number
P/16/35/9/5946
Health conditions studied
1
Description of health condition studied
apical periodontitis
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis of pulpal origin
Primary outcomes
1
Description
Evaluation of Enterococcus faecalis colonization
Timepoint
2 weeks after treatment
Method of measurement
using bacterial counts
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Irrigation of root canal with 10 ml sodium hypochlorite 6% plus chlorhexidine 0.2% and calcium hydroxide powder.
Category
Treatment - Drugs
2
Description
Irrigation of root canal with 10 ml sodium hypochlorite 6%.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry School
Full name of responsible person
Dr Parastoo Ghahari
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Dentistry School
Full name of responsible person
Dr Parastoo Ghahari
Position
Resident of Endodontic
Other areas of specialty/work
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1039
Fax
Email
ghahariparastoo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dentistry School
Full name of responsible person
Dr Zakiyeh Donyavi
Position
Endodontist
Other areas of specialty/work
Street address
Dentistry School, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1039
Fax
Email
zakiyeh_donyavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor of Epidemiology
Other areas of specialty/work
Street address
Department of Epidemiology & Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)