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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03680534
Other study ID # JCB001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2017
Est. completion date November 19, 2017

Study information

Verified date September 2018
Source Institucion Universitaria Colegios de Colombia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 19, 2017
Est. primary completion date October 23, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Colombia Facultad de Odontologia, Unicoc Bogota

Sponsors (1)

Lead Sponsor Collaborator
Institucion Universitaria Colegios de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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