Tooth Crown Discoloration Caused by Endodontic Treatment

Sponsor
Federal University of Pelotas (Other)
Overall Status
Completed
CT.gov ID
NCT03841370
Collaborator
(none)
70
1
39
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endodontic treatment

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 Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Tooth Crown Discoloration Caused by Endodontic Treatment: Cross-sectional Clinical Study
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Mar 30, 2019
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm 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.

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

Outcome Measures

Primary Outcome Measures

  1. Color alteration [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Pelotas Pelotas RS Brazil 96015-560

Sponsors and Collaborators

  • Federal University of Pelotas

Investigators

  • Principal Investigator: Noéli Boscato, PhD, Federal University of Pelotas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noéli Boscato, PhD, Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT03841370
Other Study ID Numbers:
  • FUPel
First Posted:
Feb 15, 2019
Last Update Posted:
Feb 2, 2021
Last Verified:
Feb 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2021