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3D Analysis of Root Canal Conformation

Primary Purpose

Endodontic Disease, Root Canal Infection

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Root canal preparation
Sponsored by
Institucion Universitaria Colegios de Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease focused on measuring root canal preparation, single-file preparation techniques, 3D reconstruction

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-30 years old
  2. healthy conditions
  3. not medicated with any type of drug
  4. non-smoking patients
  5. lower premolars indicated for extraction due to orthodontic reasons
  6. lower premolar with more than one root canal

Exclusion Criteria:

  1. Not willing to participate
  2. Pregnant women
  3. lower premolars with previous root canal therapy
  4. lower premolars with

Sites / Locations

  • Facultad de Odontologia, Unicoc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Reciproc Blue

WaveOne Gold

XP EndoShaper

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2018
Last Updated
September 19, 2018
Sponsor
Institucion Universitaria Colegios de Colombia
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1. Study Identification

Unique Protocol Identification Number
NCT03680534
Brief Title
3D Analysis of Root Canal Conformation
Official Title
Three-dimensional Analysis of the Root Canal Preparation With Reciproc Blue, WaveOne Gold and XP EndoShaper
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
November 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institucion Universitaria Colegios de Colombia

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Root Canal Infection
Keywords
root canal preparation, single-file preparation techniques, 3D reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reciproc Blue
Arm Type
Experimental
Arm Description
Patients in which root canal from a lower premolar was prepared with the Reciproc Blue technique.
Arm Title
WaveOne Gold
Arm Type
Experimental
Arm Description
Patients in which root canal from a lower premolar was prepared with the WaveOne Gold technique.
Arm Title
XP EndoShaper
Arm Type
Experimental
Arm Description
Patients in which root canal from a lower premolar was prepared with the XP EndoShaper technique.
Intervention Type
Procedure
Intervention Name(s)
Root canal preparation
Other Intervention Name(s)
Root canal instrumentation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Root canal volume increase in cubic millimetres after root canal preparation by using the volume command in the Rhinoceros 5.0 software
Description
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.
Time Frame
One day
Title
Root canal transportation after preparation assessed by superimposing three-dimensional reconstruction images of pre- and post-preparation
Description
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.
Time Frame
One day
Title
Centring ability of the instruments used to prepare the root canal assessed by determining if canal was enlarged equally to each of its walls
Description
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.
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-30 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 Exclusion Criteria: Not willing to participate Pregnant women lower premolars with previous root canal therapy lower premolars with
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Caviedes-Bucheli
Organizational Affiliation
Institucion Universitaria Colegios de Colombia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Odontologia, Unicoc
City
Bogota
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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3D Analysis of Root Canal Conformation

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