3D Analysis of Root Canal Conformation

Three-dimensional Analysis of the Root Canal Preparation With Reciproc Blue, WaveOne Gold and XP EndoShaper

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.

Study Overview

• Status: Completed
• Conditions: Endodontic Disease; Root Canal Infection
• Intervention / Treatment: Procedure: Root canal preparation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogota, Colombia
    • Facultad de Odontologia, Unicoc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reciproc Blue; Patients in which root canal from a lower premolar was prepared with the Reciproc Blue technique.	Procedure: Root canal preparation; 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.; Other Names: Root canal instrumentation
Experimental: WaveOne Gold; Patients in which root canal from a lower premolar was prepared with the WaveOne Gold technique.	Procedure: Root canal preparation; 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.; Other Names: Root canal instrumentation
Experimental: XP EndoShaper; Patients in which root canal from a lower premolar was prepared with the XP EndoShaper technique.	Procedure: Root canal preparation; 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.; Other Names: Root canal instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institucion Universitaria Colegios de Colombia
• Investigators: Principal Investigator: Javier Caviedes-Bucheli, Institucion Universitaria Colegios de Colombia

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): October 23, 2017
• Study Completion (Actual): November 19, 2017

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 19, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: root canal preparation; 3D reconstruction; single-file preparation techniques
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases
• Other Study ID Numbers: JCB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No