Objectives: extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment.
Although debris extrusion is an inevitable finding even when instrumentation is limited to the confines of the canal, different armamentarium seem to be associated with different amounts of debris extrusion.
Studies on the effect of various rotary files on post-endodontic pain are very few and have yielded conflicting results with some favoring full-sequence and others leaning towards reciprocal rotary systems.
This study aims at assessing the intensity of post-endodontic pain following two different rotary systems, Reciproc and One Shape.
Methods: in this single-blind, parallel-grouped randomized clinical trial a total of 150 otherwise healthy patients aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region were analyzed.
A clinician performed the endodontic treatment in three groups, a control group instrumented using K-files, a group instrumented using Oneshape and a third group with instrumentation performed using Reciproc rotary systems.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042227519N1
Registration date:2016-05-05, 1395/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Seyed Rohollah Havaei
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3234 8538
Email address
s.r.havaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University Of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of post-endodontic pain following root canal therapy by two different rotary instrumentation systems : Reciproc & Oneshape
Public title
Comparative evaluation of post-endodontic pain following root canal therapy by two different rotary instrumentation systems
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the otherwise healthy patients were aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region.
Exclusion criteria: previous endodontic treatment; a history of drug intake including corticosteroids; opioids and NSAIDs in the previous 12 hours; pregnancy; complicated anatomy (curves greater than 25 degrees); calcifications; internal & external resorption; open apices; periodontal disease; swelling & abscess; presence of periapical lesions; sensitivity to percussion and lack of occlusal contact.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02621034
Registration date
2015-11-29, 1394/09/08
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Pardis university- Dr Hesabi Square- Zahedan-Iran
City
Zahedan
Postal code
43463-98167
Approval date
2016-04-13, 1395/01/25
Ethics committee reference number
IR.ZAUMS.REC 7198
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
Pain
Timepoint
6 hours after treatment, 12 hours after treatment, 24 hours after treatment, 48 hours after treatment and 72 hours after treatment
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
1
Description
Swelling
Timepoint
6 hours after treatment, 12 hours after treatment, 24 hours after treatment, 48 hours after treatment and 72 hours after treatment
Method of measurement
Clinical assessment
Intervention groups
1
Description
Control group : using K-files via the stepback technique
Category
Treatment - Surgery
2
Description
Reciproc group : using the Reciproc system
Category
Treatment - Surgery
3
Description
Oneshape group : using the Oneshape system
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan dental school
Full name of responsible person
Seyed Roholla Havaei
Street address
Zahedan dental school
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ministry of research and development
Full name of responsible person
Ghazale Ashrafzadeh
Street address
Ministry of research and development- Zahedan- Iran
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ministry of research and development
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
Zahedan University of Medical Sciences
Full name of responsible person
Eshagh Ali Saberi
Position
Assistant Professor , DDS MS
Other areas of specialty/work
Street address
Zahedan dental school - Zahedan - Iran
City
Zahedan
Postal code
Phone
+98 54 3341 4004
Fax
Email
saberiendo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Rohollah Havaei
Position
DDS
Other areas of specialty/work
Street address
Mostafa Khomeini 16- Zahedan- Iran
City
Zahedan
Postal code
Phone
+98 54 3321 0743
Fax
Email
marty_zl@yahoo.com; s.r.havaei@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Seyed Roholla Havaei
Position
DDS
Other areas of specialty/work
Street address
Mostafa Khomeini 16
City
Zahedan
Postal code
Phone
+98 54 3321 0743
Fax
Email
marty_zl@yahoo.com; s.r.havaei@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)