Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems

July 25, 2018 updated by: Michel Karam Eissa Elias, Cairo University

Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial (Part I)

  • The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system in patients with symptomatic irreversible pulpitis.
  • Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will then start their root canal treatment on the same visit and to be completed in one visit only. Patients will be phone called in order to record the intensity of pain, amount and frequency of analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

- Full medical and dental history using a schematic dental chart will be obtained from all eligible participants. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues.

The patients will be randomly divided into 2 groups:

  • Experimental group: Reciproc reciprocating instrumentation system.

  • Control group: One Shape rotary instrumentation system.

    - Sequence of Procedural steps

    1. Preoperative pain will be assessed by Numerical Rating Scale (NRS) before administration of anesthesia.
    2. Local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline).
    3. An access cavity will be performed using round bur and Endo-Z bur.
    4. The tooth will be properly isolated with rubber dam.
    5. Working length will be determined using an electronic apex locator, and working length will be confirmed by radiograph using K-file. Then the working length will be established at 0.5 mm up to the radiographic apex.
    6. Canals will be explored with hand K-file ISO sizes 10, 15, 20.
    7. Mechanical preparation for both groups will be as follows:

  • Experimental group:

    • Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
    • There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
    • Reciproc file selection: R40 (40/0.06) is to be used.

  • Control group:

    • Coronal preflaring will be performed using Gates Glidden drill.
    • Canals will be instrumented using One Shape (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions.

    • For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used.

      8.The rotary files will be introduced inside the canal using EDTA gel. 9.Canals will be irrigated with 2.5% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27-gauge needle fit to 5 ml disposable plastic syringe placed as far as possible in the canal space without binding.

      10.Canals will be dried with sterile paper points and obturated using lateral condensation technique. A spreader will be used to allow space for auxiliary cones, with resin-based root canal sealer.

      11.The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.

      12.The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.

      13.The patient will be instructed to take one tablet 400 mg Ibuprofen if he/she experiences severe pain.

Study Type

Interventional

Enrollment (Actual)

54

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
        • Endodontic Department - 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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Single-rooted mandibular premolar teeth with:

  • Preoperative sharp pain.
  • Vital response of pulp tissue.
  • Normal periapical radiographic appearance or slight widening in lamina dura.

Exclusion Criteria:

i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.

ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.

iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively.

vi. Patients having bruxism or clenching. vii. Teeth that have:

  • Non vital pulp tissues.
  • Association with swelling or fistulous tract.
  • Pocket depth greater than 5 mm.
  • 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
  • Reciproc (VDW, Munich, Germany) is a single file reciprocating system for mechanical instrumentation of root canals.
  • Size: R40 (40/0.06)
Procedure: Reciproc
  • Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
  • There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
  • Reciproc file selection: R40 (40/0.06) is to be used.
Active Comparator: One Shape
  • One Shape (MicroMega, Besançon Cedex, France) is a single file system that works by continuous rotation for mechanical instrumentation of root canals.
  • Size: 25/0.06
Procedure: One Shape
  • Coronal preflaring will be performed using Gates Glidden drill.
  • Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions.
  • For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: Up to 72 hrs after treatment
Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)
Up to 72 hrs after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of analgesic tablets taken after endodontic treatment
Time Frame: up to 72 hours after treatment
One tablet 400 mg Ibuprofen if patient experiences severe pain after treatment
up to 72 hours after treatment

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Michel K Elias, Resident, Faculty of oral and dental medicine - cairo university
  • Study Director: Hebatallah M El-Far, Professor, Faculty of oral and dental medicine - cairo university
  • Study Chair: Shaimaa I Gawdat, Lecturer, Faculty of oral and dental medicine - 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 (Actual)

November 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 25, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBC-CU-2016-10-145

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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