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Postoperative Pain After Using NiTi Instruments

Primary Purpose

Post-Op Complication, Endodontic Inflammation, Endodontically Treated Teeth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NiTi instruments
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Op Complication focused on measuring non-surgical endodontic retreatment, post operative pain, rotary NiTi instrument, reciprocating NiTi instrument, ProTaper Universal, ProTaper Gold, Hyflex EDM, Reciproc Blue, WaveOne Gold

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Burhan Çanakçi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

ProTaper rotary NiTi instruments

Hyflex EDM rotary NiTi instruments

Reciproc Blue reciprocating NiTi instruments

Waveone Gold reciprocating NiTi instruments

Arm Description

The ProTaper Universal Retreatment rotary system and ProTaper Gold rotary system were used.

Hyflex EDM rotary system was used.

Reciproc Blue reciprocating system was used.

WaveOne Gold reciprocating system was used.

Outcomes

Primary Outcome Measures

Postoperative pain after removal of gutta-percha using four different NiTi systems.
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.

Secondary Outcome Measures

Postoperative pain after removal of gutta-percha using four different NiTi systems.
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.

Full Information

First Posted
January 5, 2021
Last Updated
January 11, 2021
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT04700995
Brief Title
Postoperative Pain After Using NiTi Instruments
Official Title
Postoperative Pain After Endodontic Retreatment Using Different Rotary or Reciprocating Instruments: A Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication, Endodontic Inflammation, Endodontically Treated Teeth, Apical Periodontitis
Keywords
non-surgical endodontic retreatment, post operative pain, rotary NiTi instrument, reciprocating NiTi instrument, ProTaper Universal, ProTaper Gold, Hyflex EDM, Reciproc Blue, WaveOne Gold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ProTaper rotary NiTi instruments
Arm Type
Experimental
Arm Description
The ProTaper Universal Retreatment rotary system and ProTaper Gold rotary system were used.
Arm Title
Hyflex EDM rotary NiTi instruments
Arm Type
Experimental
Arm Description
Hyflex EDM rotary system was used.
Arm Title
Reciproc Blue reciprocating NiTi instruments
Arm Type
Experimental
Arm Description
Reciproc Blue reciprocating system was used.
Arm Title
Waveone Gold reciprocating NiTi instruments
Arm Type
Experimental
Arm Description
WaveOne Gold reciprocating system was used.
Intervention Type
Procedure
Intervention Name(s)
NiTi instruments
Intervention Description
Root canal filling removal
Primary Outcome Measure Information:
Title
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Description
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.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Description
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.
Time Frame
24 to 48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Postoperative pain after removal of gutta-percha using four different NiTi systems.
Description
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.
Time Frame
48 to 72 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burhan Çanakçi
Organizational Affiliation
Trakya University, Faculty of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Özgür Er
Organizational Affiliation
Trakya University, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Burhan Çanakçi
City
Edirne
ZIP/Postal Code
22061
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain After Using NiTi Instruments

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