Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03841370 |
Other study ID # |
FUPel |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2017 |
Est. completion date |
December 1, 2020 |
Study information
Verified date |
February 2021 |
Source |
Federal University of Pelotas |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.