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Comparison of the effect of Chlorhexidine2% gel and Calcium hydroxide on bacterial contamination of post space

Protocol summary

Summary
the purpose of this study is to compare the effect of Calcium hydroxide and Chlorhexidine 2% gel on post space bacterial contamination.this is a randomized double blinded study with control group but no placebo.inclusion criteria:Patients who don’t receive antibiotics during the last 4 weeks;non vital single teeth which need root canal treatment and post;no systemic disease;no periapical lesion. exclusion criteria:Pain or perforation during post space preparation; loss of coronal temporary restoration during 14 days follow up. calcium hydroxide and Chlorhexidine 2% gel are used as intervention for 2 weeks. change in colony forming units counts from the root canal is the consequence of this study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041232777N1
Registration date: 2017-04-12, 1396/01/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Morteza Moattari
Name of organization / entity
Islamic Azad University, Tehran Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
mehson25@gmail.com
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Tehran Dental Branch
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of the effect of Chlorhexidine2% gel and Calcium hydroxide on bacterial contamination of post space
Public title
Comparison of the effect of Chlorhexidine and Calcium hydroxide
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Patients who don’t receive antibiotics during the last 4 weeks;non vital single root teeth which need root canal treatment and post;no systemic disease;no periapical lesion. Exclusion criteria:Pain or perforation during post space preparation; loss of coronal temporary restoration during 14 days follow up.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Tehran Dental Branch
Street address
No 4, Neyestan10th, Pasdaran st, Tehran
City
Tehran
Postal code
1946853314
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,21

Health conditions studied

1

Description of health condition studied
Dental infection
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases

Primary outcomes

1

Description
bacteria count of Streptococcus and E.feacalis
Timepoint
2 weeks after beginnig of the intervention
Method of measurement
CFU

Secondary outcomes

1

Description
other bacteria species
Timepoint
2 weeks after beginning of the intervention
Method of measurement
CFU

Intervention groups

1

Description
Chlorhexidine2% gel:for 2 weeks,intracanal injection
Category
Treatment - Drugs

2

Description
Calcium hydroxide powder: mixed with serum with creamy consistency,for 2 weeks,insertion into the canal
Category
Treatment - Drugs

3

Description
Control group:no action
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Morteza Moattari(Resident of Endodontics)
Street address
No 4, Neyestan10th, Pasdaran st, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Arash Azizi
Street address
No 4, Neyestan10th, Pasdaran st, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Tehran Dental Branch
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
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Morteza Moattari
Position
Resident of Endodontics
Other areas of specialty/work
Street address
No 4, Neyestan10th, Pasdaran st, Tehran
City
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
+98 21 2256 4577
Email
mehson25@gmal.com
Web page address
www.dentaliau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Morteza Moattari
Position
Resident of Endodontics
Other areas of specialty/work
Street address
No 4, Neyestan10th, Pasdaran st, Tehran
City
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
+98 21 2256 4577
Email
mehson25@gmail.com
Web page address
www.dentaliau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Morteza Moattari
Position
Resident of Endodontics
Other areas of specialty/work
Street address
No 4, Neyestan10th, Pasdaran st, Tehran
City
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
+98 21 2256 4577
Email
mehson25@gmail.com
Web page address
www.dentaliau.ac.ir

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
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