Endodontically Treated TeethNCT03841370
Tooth Crown Discoloration Caused by Endodontic Treatment
An observational study of Endodontically Treated Teeth and Root Canal Infection, run by Federal University of Pelotas at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth, Root Canal Infection, Tooth Discoloration
- What is being tested?
- endodontic treatment
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2017to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent endodontic treatment and who presented the homologous tooth without endodontic treatment in order to perform a color comparison measurement.
Who may be able to join
- 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
Who cannot join
- dental elements submitted to retreatment;
- files with insufficient data, and absence of quality periapical radiography
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015-560
About this study
Official title: 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.
Read the 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.
- Being tested
- endodontic treatment
- Medical subject headings
- Tooth, Nonvital, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endodontic treatmentProcedure or surgery
Color measurements of endodontically treated teeth (incisors, canines or premolar) will be collected regardless of technique, treatment time and sealer used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: endodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ranging from 1 month to 5 years after endodontic treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Sep 2017
- Primary completion30 Mar 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noéli Boscato, PhD, Federal University of Pelotas
- Investigators
- Noéli Boscato, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841370
- Sponsor's protocol ID
- FUPel
- Status last verified
- Feb 2021
- First submitted
- 19 Nov 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Crown Discoloration Caused by Endodontic Treatment: Cross-sectional Clinical Study
- ClinicalTrials.gov ID
- NCT03841370
- Acronym / sponsor ID
- FUPel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endodontic | – | Procedure: endodontic treatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent endodontic treatment and who presented the homologous tooth without endodontic treatment in order to perform a color comparison measurement.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- dental elements submitted to retreatment;
- files with insufficient data, and absence of quality periapical radiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endodontic treatmentColor measurements of endodontically treated teeth (incisors, canines or premolar) will be collected regardless of technique, treatment time and sealer used. | Procedure or surgery | endodontic |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noéli Boscato, PhD principal investigator
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endodontically Treated Teeth and Root Canal Infection, run by Federal University of Pelotas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color alteration (time frame: ranging from 1 month to 5 years after endodontic treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.