Postoperative Pain After Using NiTi Instruments

January 11, 2021 updated by: Burhan Can Çanakçi, Trakya University

Postoperative Pain After Endodontic Retreatment Using Different Rotary or Reciprocating Instruments: A Randomized, Controlled Clinical Trial

The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary (ProTaper Universal or Hyflex EDM) or reciprocating file (Reciproc Blue or WaveOne Gold) systems. The null hypothesis tested was that there is no difference in postoperative pain following the retreatment procedure between the four systems used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain (PP) is not a certain reason for the long term success of root canal treatment. However, PP control is important for patient comfort and satisfaction. Apical extrusion of debris containing dentin, necrotic pulp tissue, microorganisms, and/or irrigation solutions may occur during retreatment procedures which may result in the induction of periapical inflammation, postoperative pain, and delayed periapical healing. All available techniques and instruments are associated with apical extrusion of debris to some degree during the root canal preparation or removal of the obturation materials. The aim of this randomized clinical trial was to compare the incidence, intensity and duration of postoperative pain following the removal of root canal obturation materials canals using rotary or reciprocating file systems.

Patients referred for non-surgical endodontic retreatment were included. Hundred and eighty cases were selected on the basis of the determined inclusion criteria and randomly allocated to four groups (n = 45).

ProTaper Universal group D1, D2 and D3 files were used respectively with a full rotational motion with a endodontic motor until working was reached as recommended by the manufacturer.

Hylex EDM group Hylex EDM files were used with a full rotational motion with a endodontic motor until the working was reached.

Reciproc Blue group R25 files were used with a reciprocating motion using with the "RECIPROC ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working lenght was reached.

Waveone Gold group Primary files were used with a reciprocating motion using with the "WAVEONE ALL" mode with a slow in-and-out pecking motion, and the amplitude of pecking movements did not exceed 3 mm until the working was reached.

Assessment of postoperative pain Before participation, all patients had read and signed an informed consent form., all patients were given a pain report form on which they would report their preoperative level of pain.

Before beginning of treatment, the clinician filled in an example of pain report with each patient to confirm that they understood the instructions.

The degree of the postoperative pain was measured using an 11-level numeric rating scale (NRS) at 24, 48, and 72 h following the retreatment. The NRS is a segmented numeric version of the visual analog scale (VAS) and consists of successive numbers from 0 to 10 on a horizontal line. The respondent selects a number that best represents the intensity of his pain. Number "0" represents "no pain" whereas number "10" represents "the worst pain imaginable".

Patients were asked to fill out forms at relevant times in accordance with the instructions given.

An analgesic tablet (400 mg Ibuprofen) was prescribed to take an in case of severe pain, at 6-h intervals. Also they were requested to record the number of analgesic pills consumed each day. The forms were collected on the 4th day following the retreatment. Also a phone call was made every day for 3 days to obtain information on the postoperative pain and the frequency of analgesic intake. The patients were asked to call the contact number on the form if they encountered severe pain or if they needed to ask any questions regarding the treatment.

Study Type

Interventional

Enrollment (Actual)

180

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

  • Turkey
      • Edirne, Turkey, 22061
        • Burhan Çanakçi

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Systemically healthy patient who has a failed root canal treatment.
  • Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
  • Patients agreed to parcitipate in the study

Exclusion Criteria:

  • Overfilled teeth,
  • teeth with intraradicular posts,
  • existence of a sinus tract,
  • consumption of antibiotics or analgesics within one month,
  • pregnancy,
  • history of trauma,
  • traumatic occlusion

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ProTaper rotary NiTi instruments
The ProTaper Universal Retreatment rotary system and ProTaper Gold rotary system were used.
Procedure: NiTi instruments
Root canal filling removal
Experimental: Hyflex EDM rotary NiTi instruments
Hyflex EDM rotary system was used.
Procedure: NiTi instruments
Root canal filling removal
Experimental: Reciproc Blue reciprocating NiTi instruments
Reciproc Blue reciprocating system was used.
Procedure: NiTi instruments
Root canal filling removal
Experimental: Waveone Gold reciprocating NiTi instruments
WaveOne Gold reciprocating system was used.
Procedure: NiTi instruments
Root canal filling removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time Frame: 24 hours postoperatively
Pain intensity was evaluated at 24 hours after retreatment procedures. An 11 item numerical rating scale (NSR) was used to assess the pain. The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine". All patients were requested to mark a number corresponding to their average pain.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time Frame: 24 to 48 hours postoperatively
Pain intensity was evaluated at 48 hours after retreatment procedures. An 11 item numerical rating scale (NSR) was used to assess the pain. The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine". All patients were requested to mark a number corresponding to their average pain.
24 to 48 hours postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Time Frame: 48 to 72 hours postoperatively
Pain intensity was evaluated at 72 hours after retreatment procedures. An 11 item numerical rating scale (NSR) was used to assess the pain. The NSR is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The number 0 represents "no pain" wheres number 10 represents "pain as bad as someone can imagine". All patients were requested to mark a number corresponding to their average pain.
48 to 72 hours postoperatively

Collaborators and Investigators

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

Sponsor

Trakya University

Investigators

  • Principal Investigator: Burhan Çanakçi, Trakya University, Faculty of Dentistry
  • Study Director: Özgür Er, Trakya University, Faculty of Dentistry

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)

May 1, 2020

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 10, 2020

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TrakyaU 2020/150

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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