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Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
mtwo rotary system
safe-sider rotary system
hand files
Sponsored by
Zahedan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Instrumentation, Post-operative pain, Root canal preparation

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age range 20-50 years
  • the systemically healthy
  • first or second molar teeth require root canal therapy
  • irreversible Pulpitis signed without the apical
  • root canal curvature of less than 25 degrees, according to Schneider techniques

Exclusion Criteria:

  • Root canal treatment,
  • history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment ,
  • pregnancy,
  • complex anatomy,
  • channels blocked in the x-ray plate,
  • internal and external resorption,
  • open apex teeth,
  • periodontal disease,
  • inflammation and abscesses,
  • sinus tract,
  • presence of radiographic lesions,
  • tooth sensitivity to percussion,
  • absence of occlusal contact .

Sites / Locations

  • Zahedan University of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mtwo rotary system

safe-sider rotary system

hand files

Arm Description

( continuous rotation system)

(reciprocating system)

k-files

Outcomes

Primary Outcome Measures

Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2015
Last Updated
December 29, 2015
Sponsor
Zahedan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02644031
Brief Title
Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider
Official Title
Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zahedan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a complicated multi factorial process and is affected by factors related to patients, to the tooth and to the skills and experience of the dentist and because of that, if the interrelation of these factors is not considered in a PP, study data might be confusing. Any study trying to evaluate the effect of a specific technique or new device in the incidence or characteristics of PP should control all the confounding factors that have been described to be involved in the tested outcome. reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations are because of the differences in study methods, and treatment procedures after root canal treatment, selection of patients or experience and skills of the dentists, vary when different studies are compared. Many studies had confirmed that chemomechanical debridement of the root canal results in extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and root canal irrigants through the apical foramen. All preparation techniques and instruments, regardless of maintaining shorter working length of the apical terminus have reported to be related with extrusion of infected debris, and some of them extruded less material and others extruded more. Periapical inflammation and postoperative flare-ups may result from apical extrusion of debris that is also referred to as the "worm" of necrotic debris A common outcome of the studies examining the amount of apically extruded debris was that the techniques involving a push-pull filing motion usually produce a greater mass of apical debris than those have rotational action Files which has reciprocating and in-and-out filing motion, may act as a piston, extruding more debris and irrigants. While the file with continuous rotation motion like a screw conveyor improving transportation of dentinal chips and debris coronally. In this study, investigators compare post-endodontic pain between these two systems. Mtwo ( continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of this study is Evaluation of post-endodontic pain after root canal treatment with two rotary systems: Mtwo & safe-sider

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Instrumentation, Post-operative pain, Root canal preparation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mtwo rotary system
Arm Type
Experimental
Arm Description
( continuous rotation system)
Arm Title
safe-sider rotary system
Arm Type
Experimental
Arm Description
(reciprocating system)
Arm Title
hand files
Arm Type
Experimental
Arm Description
k-files
Intervention Type
Procedure
Intervention Name(s)
mtwo rotary system
Intervention Description
post-treatment pain after using mtwo rotary system
Intervention Type
Procedure
Intervention Name(s)
safe-sider rotary system
Intervention Description
post-treatment pain after using safe-sider rotary system
Intervention Type
Procedure
Intervention Name(s)
hand files
Intervention Description
post-treatment pain after using hand files
Primary Outcome Measure Information:
Title
Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age range 20-50 years the systemically healthy first or second molar teeth require root canal therapy irreversible Pulpitis signed without the apical root canal curvature of less than 25 degrees, according to Schneider techniques Exclusion Criteria: Root canal treatment, history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment , pregnancy, complex anatomy, channels blocked in the x-ray plate, internal and external resorption, open apex teeth, periodontal disease, inflammation and abscesses, sinus tract, presence of radiographic lesions, tooth sensitivity to percussion, absence of occlusal contact .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
arezoo hooshmandi, postgraduate
Phone
00989177089315
Email
hooshmandi_arezoo@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eshaghali saberi, professor
Organizational Affiliation
professor of endodontics department
Official's Role
Study Chair
Facility Information:
Facility Name
Zahedan University of Medical Science
City
Zahedan
State/Province
Sistan and Baloochestan
ZIP/Postal Code
98176699693
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
arezoo hooshmandi, postgraduate
Phone
00989177089315
Email
hooshmandi_arezoo@yahoo.com
First Name & Middle Initial & Last Name & Degree
rohollah havaei

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider

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