Endodontically Treated TeethNCT03841877
Color Dental Alteration Caused by Endodontic Treatment
A study testing endodontic treatment in people with Endodontically Treated Teeth and Tooth Discoloration, 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, Tooth Discoloration, Root Canal Infection
- What is being tested?
- endodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Dec 2018to 15 Mar 2020
- Phase
- Interventional
- 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
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
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 randomized clinical trial (RCT) will be conducted with the objective of evaluating ΔE00 originated from epoxy resin (AH Plus) and mineral trioxide aggregate (MTA Fillapex) endodontic sealers, sectioned at the cervical level and 2 mm below, in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
Read the detailed description
The sample syze determined that 48 anterior teeth (incisors and canines) and posterior teeth (premolars) should be included in the study. The sealer and cut will be randomly determined at time of endodontic treatment, originating four groups (n = 12): AH Plus-Cervical, MTA Fillapex-Cervical, AH Plus-2mm and MTA-2mm. The endodontic access cavities will be sealed with resin composed of the color of the dental element. The mean, standard deviation and confidence interval (CI 95%) of the values of ΔE00 obtained for each sealer will be initially analyzed using the variable cut level (cervical or 2mm) using the T test. Indeed, the values of ΔE00 will be analyzed by two-way analysis of variance, where the level of the cut and the type of sealer will be the factors under study.
- 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
The operator will remove the pulp inside the tooth, clean, disinfect and shaping the root canals and seal the space with endodontic sealer.
| Study group | Role | What they receive |
|---|---|---|
| AH Plus-Cervical | Experimental | The objective is evaluate the color change (ΔE00) originated from epoxy resin (AH Plus) endodontic sealer, sectioned at the cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
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 |
| MTA Fillapex-Cervical | Experimental | The objective is evaluate the color change (ΔE00) originated from mineral trioxide aggregate (MTA Fillapex) endodontic sealer, sectioned at the cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
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 |
| AH Plus-2mm | Experimental | The objective is evaluate the color change (ΔE00) originated from epoxy resin (AH Plus) endodontic sealer, sectioned 2 mm below cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
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 |
| MTA Fillapex-2mm | Experimental | The objective is evaluate the color change (ΔE00) originated from mineral trioxide aggregate (MTA Fillapex) endodontic sealer, sectioned 2 mm below cervical level.
The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
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 change
Color alteration will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically. Data will be analyzed according to sealer, cut and time
Measured: After immediate endodontic treatment versus after 3, 6 and 12 months
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 start15 Dec 2018
- Primary completion15 Dec 2019
- Study completion15 Mar 2020
Why it stopped: There were not participants to complete sample size
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841877
- Sponsor's protocol ID
- FUfpel 2
- Status last verified
- Feb 2021
- First submitted
- 11 Nov 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Dental Alteration Caused by Endodontic Treatment
- ClinicalTrials.gov ID
- NCT03841877
- Acronym / sponsor ID
- FUfpel 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There were not participants to complete sample size
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Mar 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 randomized clinical trial (RCT) will be conducted with the objective of evaluating ΔE00 originated from epoxy resin (AH Plus) and mineral trioxide aggregate (MTA Fillapex) endodontic sealers, sectioned at the cervical level and 2 mm below, in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.
Detailed description
The sample syze determined that 48 anterior teeth (incisors and canines) and posterior teeth (premolars) should be included in the study. The sealer and cut will be randomly determined at time of endodontic treatment, originating four groups (n = 12): AH Plus-Cervical, MTA Fillapex-Cervical, AH Plus-2mm and MTA-2mm. The endodontic access cavities will be sealed with resin composed of the color of the dental element. The mean, standard deviation and confidence interval (CI 95%) of the values of ΔE00 obtained for each sealer will be initially analyzed using the variable cut level (cervical or 2mm) using the T test. Indeed, the values of ΔE00 will be analyzed by two-way analysis of variance, where the level of the cut and the type of sealer will be the factors under study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AH Plus-Cervical | Experimental | Procedure: endodontic treatmentThe objective is evaluate the color change (ΔE00) originated from epoxy resin (AH Plus) endodontic sealer, sectioned at the cervical level. The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months. 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. |
| MTA Fillapex-Cervical | Experimental | Procedure: endodontic treatmentThe objective is evaluate the color change (ΔE00) originated from mineral trioxide aggregate (MTA Fillapex) endodontic sealer, sectioned at the cervical level. The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months. 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. |
| AH Plus-2mm | Experimental | Procedure: endodontic treatmentThe objective is evaluate the color change (ΔE00) originated from epoxy resin (AH Plus) endodontic sealer, sectioned 2 mm below cervical level. The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months. 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. |
| MTA Fillapex-2mm | Experimental | Procedure: endodontic treatmentThe objective is evaluate the color change (ΔE00) originated from mineral trioxide aggregate (MTA Fillapex) endodontic sealer, sectioned 2 mm below cervical level. The ΔE00 will be evaluated using the measurements data obtained in a period between the immediate endodontic treatment versus after 3, 6 and 12 months. 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
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 treatmentThe operator will remove the pulp inside the tooth, clean, disinfect and shaping the root canals and seal the space with endodontic sealer. | Procedure or surgery | AH Plus-2mm, AH Plus-Cervical, MTA Fillapex-2mm, MTA Fillapex-Cervical |
Primary outcome
Color change
Time frame: After immediate endodontic treatment versus after 3, 6 and 12 months
Color alteration will be evaluated using the measurements obtained in the homologous tooth (without endodontic treatment) versus the measurement obtained from the tooth treated endodontically. Data will be analyzed according to sealer, cut and time
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endodontic treatment in people with Endodontically Treated Teeth and Tooth Discoloration, 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: withdrawn, as of the sponsor's last update on 3 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 was withdrawn before enrolling participants, so there are no results.
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 change (time frame: After immediate endodontic treatment versus after 3, 6 and 12 months). 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 3 Feb 2021.