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OpenTrials
Completed

NCT Number: NCT03680534

3D Analysis of Root Canal Conformation

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.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Root Canal Infection Stomatognathic Diseases Tooth Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Odontologia, Unicoc

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Root canal preparation

Procedure

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

Primary outcomes

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

    Time frame: One day

    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.

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

    Time frame: One day

    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.

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

    Time frame: One day

    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.

Sponsors and collaborators

Lead sponsor

Institucion Universitaria Colegios de Colombia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2018
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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