Postoperative Pain Associated With Three Endodontic Rotary Systems

February 22, 2017 updated by: Ola Adel Hassan Hafez, Cairo University

Evaluation of Postoperative Pain After Single Visit Root Canal Treatment Associated With The Three Rotary Systems; ONE ENDO, F6 SkyTper and ProTaper Universal. (Randomized Controlled Clinical Trial)

Assessment of postoperative pain after root canal treatment using different rotary systems.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.

Study Type

Interventional

Enrollment (Anticipated)

57

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
        • Recruiting
        • Faculty of oral and dental medicine - 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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systematically healthy patients,
  • maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment.

Exclusion Criteria:

  • Non-vital teeth,
  • teeth with apical periodontitis,
  • teeth requiring endodontic retreatment,
  • root resorption,
  • immature / open apex,
  • root canals with radiographic evidence of calcification,
  • presence of more than one symptomatic tooth in the same quadrant,
  • pregnancy,
  • medically compromised patients,
  • patients receiving medication for chronic pain,
  • patients who have taken analgesics in the last 12 hours before treatment.
  • teeth that have initial apical size more than 20,
  • teeth that could not be treated in a single session,
  • if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.

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: ONE ENDO
Single file rotary system
Device: ONE ENDO
single file rotary system
Experimental: F6 SKYTaper
Single file rotary system
Device: F6 SKYTaper
single file rotary system
Active Comparator: ProTaper Universal
Muti-file rotary system
Device: ProTaper Universal
multi-file rotary system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: up to 72 hours after endodontic treatment

Verbal Rating Scale (VRS) with the following scores:

0. No pain.

  1. Mild pain: any discomfort of any duration that does not require analgesics.
  2. Moderate pain: pain that requires and is relieved with analgesics.
  3. Severe pain: any pain that is not relieved with analgesics.
up to 72 hours after endodontic treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of analgesics consumed
Time Frame: up to 72 hours after endodontic treatment
up to 72 hours after endodontic treatment

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ola A. Hafez, MD Student, Faculty of oral and dental medicine - cairo university
  • Study Chair: Alaa El-Din H. Diab, Professor, Faculty of oral and dental medicine - cairo university
  • Study Director: Kareem G. Abd El-Kader, Assistant Professor, Faculty of oral and dental medicine - cairo university

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 (Actual)

October 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2016-11-173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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