Tooth Crown Discoloration Caused by Endodontic Treatment

February 1, 2021 updated by: Noéli Boscato, PhD, Federal University of Pelotas

Tooth Crown Discoloration Caused by Endodontic Treatment: Cross-sectional Clinical Study

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.

Study Overview

Detailed Description

This cross-sectional clinical study will evaluate the color difference (∆E00), and CIELAB coordinates (L*, a*, and b*) of endodontic treated teeth in the 3 conditions (baseline, homologous tooth versus ≤ 1 month after tooth endodontic treatment); (baseline, homologous tooth versus > 1 to 12 months after tooth endodontic treatment); (baseline, homologous tooth versus > 12 up to 5 years after tooth endodontic treatment). The following pairs of variables will be considered in the comparisons: filling material (AH Plus and Endofill/Fillcanal/MTA Fillapex); cut at cervical level (dental cervix and 2mm in the apical direction); and location tooth (anterior and posterior teeth).

The response variables will include the color difference (∆E00), estimated by the CIEDE2000 color difference metric (ΔE00) obtained from readings made on the homologous tooth of the endodontic treated (baseline) and tooth endodontic treated (after) with a spectrophotometer.

All individuals who came to a private dental clinic between January 2010 and December 2018 and who received endodontic treatment will be considered for participation in this study. The following inclusion criteria will be used to evaluate and enroll potential participants: individuals at least 18 years old; who received anterior or posterior (pre-molar) endodontic treatment and who present homologous tooth with pulp vitality and at least 1/3 of the remaining coronary, without endodontic treatment, intraradicular retentor or crown making dental color assessment impossible. Besides, will be excluded questionnaires filled incorrectly or lack of data regarding, the day, month and year of endodontic treatment finish, sealer used, the pulp condition at the time of the first consultation (irreversible pulpitis or pulpal necrosis) and periapical radiography, obtained with the use of radiographic positioner, preserved and with a clear image. All individuals who agree to participate in the study will sign a consent form based on the Declaration of Helsinki, after receiving information about the study objectives, risks, and benefits associated with the alternative treatment options and procedures. One examiner will be trained and calibrated prior to data collection. Kappa statistics will be used to assess intra-examiner reliability. Clinical, radiographic and color information will be collected.

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RS
      • Pelotas, RS, Brazil, 96015-560
        • Federal University of Pelotas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color alteration
Time Frame: ranging from 1 month to 5 years after endodontic treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

March 30, 2019

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

February 13, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • FUPel

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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