NCT03841370

Brief Summary

The color change of endodontically treated teeth is a common concern in clinical practice. The objective of this study will be to evaluate, in vivo, the color change (ΔE00) caused by endodontic treatment. A observational retrospective study will be conducted to evaluate the ΔE00 of anterior (incisors and canines) and posterior (premolar) teeth treated at a private clinic, regardless of technique, treatment time and sealer used. In this study the ΔE00 will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically. The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

November 19, 2018

Last Update Submit

February 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Color alteration

    Color alteration (CIEDE2000 color difference metric - ΔE00) will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically.

    ranging from 1 month to 5 years after endodontic treatment.

Study Arms (1)

endodontic

The color of anterior (incisors and canines) and posterior (premolar) teeth treated at a private clinic in the city of Pelotas will be evaluated. Data will be collected regardless of technique, treatment time and sealer used. The ΔE00 will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically. The values of ΔE00 obtained for each sealer, cut and time will be analyzed by multifactorial analysis to verify associations of the outcomes with the ΔE00.

Procedure: endodontic treatment

Interventions

Color measurements of endodontically treated teeth (incisors, canines or premolar) will be collected regardless of technique, treatment time and sealer used.

endodontic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent endodontic treatment and who presented the homologous tooth without endodontic treatment in order to perform a color comparison measurement.

You may qualify if:

  • endodontically treated tooth, without intraradicular retainer and fixation;
  • presence of homologous tooth to that treated, with pulp vitality and at least 1/3 of the crown;
  • correctly patient's file showing the endodontic treatment day, the endodontic filler used, the pulp condition at the first consultation, and periapical radiography, obtained with the use of a radiographic positioner, preserved and with a clear apical image

You may not qualify if:

  • dental elements submitted to retreatment;
  • files with insufficient data, and absence of quality periapical radiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Location

MeSH Terms

Conditions

Tooth, NonvitalTooth Discoloration

Interventions

Endodontics

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Noéli Boscato, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2018

First Posted

February 15, 2019

Study Start

September 1, 2017

Primary Completion

March 30, 2019

Study Completion

December 1, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations