NCT04700995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 5, 2021

Last Update Submit

January 11, 2021

Conditions

Post-Op ComplicationEndodontic InflammationEndodontically Treated TeethApical Periodontitis

Keywords

non-surgical endodontic retreatmentpost operative painrotary NiTi instrumentreciprocating NiTi instrumentProTaper UniversalProTaper GoldHyflex EDMReciproc BlueWaveOne Gold

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours postoperatively

Secondary Outcomes (1)

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

    24 to 48 hours postoperatively

Other Outcomes (1)

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

    48 to 72 hours postoperatively

Study Arms (4)

ProTaper rotary NiTi instruments

EXPERIMENTAL

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

Procedure: NiTi instruments

Hyflex EDM rotary NiTi instruments

EXPERIMENTAL

Hyflex EDM rotary system was used.

Procedure: NiTi instruments

Reciproc Blue reciprocating NiTi instruments

EXPERIMENTAL

Reciproc Blue reciprocating system was used.

Procedure: NiTi instruments

Waveone Gold reciprocating NiTi instruments

EXPERIMENTAL

WaveOne Gold reciprocating system was used.

Procedure: NiTi instruments

Interventions

NiTi instrumentsPROCEDURE

Root canal filling removal

Hyflex EDM rotary NiTi instrumentsProTaper rotary NiTi instrumentsReciproc Blue reciprocating NiTi instrumentsWaveone Gold reciprocating NiTi instruments

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burhan Çanakçi

Edirne, 22061, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative ComplicationsPulpitisTooth, NonvitalPeriapical PeriodontitisPain, Postoperative

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDental Pulp DiseasesTooth DiseasesStomatognathic DiseasesPeriapical DiseasesJaw DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Burhan Çanakçi

    Trakya University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

  • Özgür Er

    Trakya University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 8, 2021

Study Start

May 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 10, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)