Protocol summary

Summary
Aim: A comparison of two different concentrations of NaOCl on pain following single-visit root canal treatment. Methods: This study will be performed as a randomized triple-blinded clinical trial on 100 patients. The patients will be randomly allocated in two groups of 50 each and their root canals will be irrigated with either 5.25 or 2.5% of sodium hypochlorite. Inclusion criteria:No systemic disease, first and second mandibular molar with irreversible pulpitis, normal preapical radiography, mild sensitivity to percussion, no or mild pretreatment pain, having no medication at least 6 hours before the treatment visit, at least 18 years, no allergic reaction to the lidocaine with epinephrine 1:80000, gelofen, and sodium hypochlorite. Exclusion criteria: Pregnancy and lactation, severe periodontal diseases, over instrumentation or overfilling, teeth that cannot be isolated, root canal calcification, root resorption, and the teeth that cannot be restored. Root canals will be prepared in crown-down manner and RaCe rotary instruments. At the same visit the root canals will be obturated with cold lateral condensation technique using gutta-percha and AH26 root canal sealer. At the end of treatment visit, each patient will receive one cap of Gelofen (400 mg). The patients will be given two forms. A visual analogue scale form that records the they rate the severity of their pain during 7 days period following the treatment. The other form is pertaining to analgesic consumption. Statistical analysis will be performed by someone else using who will be unaware of the intervention.

General information

Acronym
Hypochlorite
IRCT registration information
IRCT registration number: IRCT201601202016N6
Registration date: 2016-01-24, 1394/11/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-24, 1394/11/04
Registrant information
Name
Masoud Parirokh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1245 7931
Email address
m_parirokh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences
Expected recruitment start date
2016-01-15, 1394/10/25
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of irrigation with two concentration of sodium hypochlorite on postoperative pain following single-visit endodontic treatment: A triple blinded randomized clinical trial
Public title
Effect of concentration of irrigants on endodontic postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no systemic disease; first and second mandibular molar with irreversible pulpitis; normal preapical radiography; mild sensitivity to percussion; no or mild pretreatment pain; having no medication at least 6 hours before the treatment visit; age at least 18 years old; no allergic reaction to the lidocaine with epinephrine 1:80000, gelofen, and sodium hypochlorite. Exclusion criteria: pregnancy and lactation; severe periodontal diseases; over instrumentation or overfilling; teeth that cannot be isolated; root canal calcification; root resorption; and the teeth that cannot be restored.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Kerman University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Tahmasbabad Cross road, Kerman, Iran.
City
Kerman
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.KMU.REC.1394.293

Health conditions studied

1

Description of health condition studied
Irreversible Pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Postoperative pain
Timepoint
Six, 12, 24, 48, 72 hours and 4, 5, 6, 7 days following the treatment
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Analgesic consumption
Timepoint
6, 12, 24, 48, 72 hours and 4, 5, 6, 7 days following the treatment
Method of measurement
Using a specific form

Intervention groups

1

Description
Intervention: 2.5% sodium hypochlorite will be used for irrigation during root canal preparation. Between instrumentation with each file to the next instrument, the root canals will be rinsed with 2mL of either of the irrigants. The needle will penetrate the root canals 2mm shorter than the working length.
Category
Treatment - Other

2

Description
Control: 5.25% sodium hypochlorite will be used for irrigation during root canal preparation. Between instrumentation with each file to the next instrument, the root canals will be rinsed with 2mL of either of the irrigants. The needle will penetrate the root canal 2mm shorter than the working length.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endodontic Department, Kerman Dental School
Full name of responsible person
Masoud Parirokh
Street address
School of Dentistry, Shafa street
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Tahmasbabad cross road, Vice Chancellor for Research and Technology building
City
Kerman
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 and Technology
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
Endodontology Research Center
Full name of responsible person
Dr. Arash Shahravan
Position
Dean of the center
Other areas of specialty/work
Street address
Kowsar square, Institute of Applied Research in Dentistry
City
Kerman
Postal code
Phone
+98 343212065
Fax
Email
arashahravan@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endodontics Department, School of Dentistry
Full name of responsible person
Masoud Parirokh
Position
Full Professor
Other areas of specialty/work
Street address
Endodontic Department, School of Dentistry, Shafa street
City
Kerman
Postal code
Phone
+98 34 3245 7931
Fax
Email
masoudparirokh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman School of Dentistry
Full name of responsible person
Masoud Parirokh
Position
Postgraduate student
Other areas of specialty/work
Street address
Endodontic Department, School of Dentistry, Shafa street
City
Kerman
Postal code
Phone
+98 34 3245 7931
Fax
Email
masoudparirokh@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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