Comparison Between Reciproc and Protaper Next

November 4, 2017 updated by: Amr Ayman Abo El Enin Ahmed, Cairo University

Comparison of Postoperative Pain After Root Canal Instrumentation Using Reciproc and ProTaper Next in Asymptomatic Necrotic Molars: A Randomized Clinical Trial

Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using Reciproc Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24 and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24 hours following obturation. The time required to complete instrumentation is also measured and compared using the two files.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Egypt
      • Cairo, Egypt, 52431
        • Cairo University

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

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis

Exclusion Criteria:

  • Patients on medication for chronic pain
  • Patients with pre-operative pain.
  • Patients having significant systemic disorders.
  • Patients with two or more adjacent teeth requiring root canal therapy
  • teeth that have vital pulp tissues, greater than grade I mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic treatment.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reciproc file
Reciproc files in reciprocating motion
Procedure: Reciproc files in reciprocating motion
An endodontic file that works through a reciprocating motion
Active Comparator: ProTaper Next file
ProTaper Next files in continuous rotary motion
Procedure: ProTaper Next files in continuous rotary motion
An endodontic file that works through a continuous rotary motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain assessed with the Numerical Rating Pain Scale
Time Frame: Up to 48 hours post-instrumentation
1 to 10 Numerical Rating Pain Scale up to 48 hours post-instrumentation
Up to 48 hours post-instrumentation
Post-obturation pain assessed with the Numerical Rating Pain Scale
Time Frame: up to 24 hours following obturation
1 to 10 Numerical Rating Pain Scale up to 24 hours following obturation
up to 24 hours following obturation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to complete instrumentation
Time Frame: From the completion of the access cavity preparation till the end of cleaning and shaping procedure up to 2 hours
time required to complete instrumentation
From the completion of the access cavity preparation till the end of cleaning and shaping procedure up to 2 hours

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2016

Primary Completion (Actual)

October 14, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 4, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • reciproc_protapernext

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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