Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems

April 29, 2016 updated by: Zahedan University of Medical Sciences

Comparison of Post-endodontic Pain Using Reciproc and Oneshape Rotary Instrumentation Systems: A Randomized Clinical Trial

In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of the post operative pain with two rotary systems including Reciproc and One shape.

Confounding factors were neutralized and the rotary systems were compared.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systematically healthy patients
  • First or second molars with irreversible pulpitis without periapical pathosis.
  • Single visit endodontic treatment

Exclusion Criteria:

  • Root canal retreatment
  • Pregnancy
  • The presence of a difficult root canal anatomy
  • Internal or external resorption
  • Teeth with open apices
  • Any accident of complication occurred during treatment
  • Presence of periapical lesion, abscess or sinus tract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
K-file hand instrumentation
Procedure: Control
K-file hand instrumentation
Experimental: Reciproc
rotary reciprocating protocol
Procedure: Reciproc
reciprocating rotary instrument
Experimental: One shape
one shape continuous rotation protocol
Procedure: One shape
full rotation protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval
Time Frame: 6 hours
The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
6 hours
Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals
Time Frame: 72 hours
72 hours
Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zahedan University of Medical Sciences

Investigators

  • Study Director: Eshagh Ali Saberi, DDS,MS, Head of the department of Endodontics, Zahedan university of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 29, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SRH-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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