NCT03680534

Brief Summary

Aim To evaluate in vivo the shaping ability of the canal with 3 different single-file systems: Reciproc Blue, WaveOne Gold and XP Endo-Shaper, using cone beam computed tomography and 3D reconstructions to measure canal volume increase, centering ability of the instruments and canal transportation in human premolars in vivo. Methodology Thirty human lower premolars were randomly divided into three groups, in which root canals were prepared using one of these single-file systems: Reciproc Blue, WaveOne Gold, and XP EndoShaper. Root canals were scanned before and after root canal preparation by using CBCT and 3D reconstruction was carried out to evaluate canal volume increase, centering ability of the instrument and canal transportation for each group. Statistical analysis was made for each variable to determine statistically significant differences between groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

2 months

First QC Date

September 17, 2018

Last Update Submit

September 19, 2018

Conditions

Keywords

root canal preparationsingle-file preparation techniques3D reconstruction

Outcome Measures

Primary Outcomes (3)

  • Root canal volume increase in cubic millimetres after root canal preparation by using the volume command in the Rhinoceros 5.0 software

    The total volume of the root canal measured before and after root canal preparation by using the volume command in the Rhinoceros 5.0 software which gives the volume of a solid in cubic millimetres.

    One day

  • Root canal transportation after preparation assessed by superimposing three-dimensional reconstruction images of pre- and post-preparation

    Deviation of the original anatomy of the canal to the mesial or distal wall after root canal preparation evaluated by superimposing three-dimensional reconstruction images of the canal before and after preparation.

    One day

  • Centring ability of the instruments used to prepare the root canal assessed by determining if canal was enlarged equally to each of its walls

    Ability of the instruments used for root canal preparation to equally enlarge all of the canal walls, evaluated by analysing superimposed three-dimensional reconstructed images of before and after root canal preparation.

    One day

Study Arms (3)

Reciproc Blue

EXPERIMENTAL

Patients in which root canal from a lower premolar was prepared with the Reciproc Blue technique.

Procedure: Root canal preparation

WaveOne Gold

EXPERIMENTAL

Patients in which root canal from a lower premolar was prepared with the WaveOne Gold technique.

Procedure: Root canal preparation

XP EndoShaper

EXPERIMENTAL

Patients in which root canal from a lower premolar was prepared with the XP EndoShaper technique.

Procedure: Root canal preparation

Interventions

Root canals from lower premolars with extraction indicated were prepared previous to being extracted with either the Reciproc Blue, the WaveOne Gold or the XP EndoShaper single-file techniques.

Also known as: Root canal instrumentation
Reciproc BlueWaveOne GoldXP EndoShaper

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • healthy conditions
  • not medicated with any type of drug
  • non-smoking patients
  • lower premolars indicated for extraction due to orthodontic reasons
  • lower premolar with more than one root canal

You may not qualify if:

  • Not willing to participate
  • Pregnant women
  • lower premolars with previous root canal therapy
  • lower premolars with

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Odontologia, Unicoc

Bogotá, Colombia

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Root Canal Preparation

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Root Canal TherapyEndodonticsDentistryTooth Preparation

Study Officials

  • Javier Caviedes-Bucheli

    Institucion Universitaria Colegios de Colombia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head and Professor of Postgraduate Endodontics Department

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 21, 2018

Study Start

August 24, 2017

Primary Completion

October 23, 2017

Study Completion

November 19, 2017

Last Updated

September 21, 2018

Record last verified: 2018-09

Locations