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Color Dental Alteration Caused by Endodontic Treatment
1 other identifier
interventional
N/A
1 country
1
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 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.
Trial Health
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Started Dec 2018
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2018
CompletedStudy Start
First participant enrolled
December 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedFebruary 3, 2021
February 1, 2021
1 year
November 11, 2018
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
After immediate endodontic treatment versus after 3, 6 and 12 months
Study Arms (4)
AH Plus-Cervical
EXPERIMENTALThe 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
EXPERIMENTALThe 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
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
Interventions
The operator will remove the pulp inside the tooth, clean, disinfect and shaping the root canals and seal the space with endodontic sealer.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- dental elements submitted to retreatment;
- files with insufficient data, and absence of quality periapical radiography
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015-560, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 11, 2018
First Posted
February 15, 2019
Study Start
December 15, 2018
Primary Completion
December 15, 2019
Study Completion
March 15, 2020
Last Updated
February 3, 2021
Record last verified: 2021-02