Color Dental Alteration Caused by Endodontic Treatment

Endodontically Treated Teeth Clinical Trial

Official title:

Color Dental Alteration Caused by Endodontic Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03841877
• Other study ID #: FUfpel 2
• Status: Withdrawn
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: February 2021
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Root Canal Infection
• Tooth Discoloration
• Tooth, Nonvital

Intervention

Procedure:
• endodontic treatment
The operator will remove the pulp inside the tooth, clean, disinfect and shaping the root canals and seal the space with endodontic sealer.

Locations

Country	Name	City	State
Brazil	Federal University of Pelotas	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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