NCT02768311

Brief Summary

Today, dentists tend to use rotary systems. Despite the increasing diversity of these systems as well as a few studies on the prevalence of pain after root canal treatment by rotary systems, And in particular, comparing the amount of pain after treatment, between systems RECIPROCAL AND FULL ROTATION single-file, the aim of this study was to evaluate the effect of applying canal preparation by the system, Neolix and WaveOne, on the prevalence of pain after endodontic treatments.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

May 11, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

May 9, 2016

Last Update Submit

May 10, 2016

Conditions

Keywords

Instrumentation Post-operative pain Root canal preparation

Outcome Measures

Primary Outcomes (1)

  • Information regarding post-operation pain is gathered via a patient using questionnaire and is measured via the visual analogue scale

    12 month

Study Arms (3)

neolix rotary system (continuous rotation system)

EXPERIMENTAL

Procedure: neolix rotary system post-treatment pain after using neolix rotary system

Procedure: neolix rotary system (continuous rotation system)

waveone rotary system (reciprocating system)

EXPERIMENTAL

Procedure: waveone rotary system post-treatment pain after using waveone rotary system

Procedure: waveone rotary system (reciprocating system)

hand files k-files

EXPERIMENTAL

Procedure: hand files post-treatment pain after using hand files

Procedure: hand files k-files

Interventions

Procedure: neolix rotary system

neolix rotary system (continuous rotation system)

Procedure: waveone rotary system

waveone rotary system (reciprocating system)

Procedure: hand files k-files

hand files k-files

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 20-50 years,
  • the systemically healthy,
  • first or second molar teeth require root canal therapy,
  • irreversible Pulpitis signed without the apical,
  • root canal curvature of less than 25 degrees, according to Schneider techniques.

You may not qualify if:

  • Root canal treatment,
  • history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment,
  • pregnancy,
  • complex anatomy,
  • channels blocked in the x-ray plate,
  • internal and external resorption,
  • open apex teeth,
  • periodontal disease,
  • inflammation and abscesses,
  • sinus tract,
  • presence of radiographic lesions,
  • tooth sensitivity to percussion,
  • absence of occlusal contact.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Last Updated

May 11, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share