Color Dental Alteration Caused by Endodontic Treatment

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.

Study Overview

• Status: Withdrawn
• Conditions: Endodontically Treated Teeth; Tooth Discoloration; Root Canal Infection
• Intervention / Treatment: Procedure: endodontic treatment

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015-560
      • Federal University of Pelotas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AH Plus-Cervical; 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.	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.
Experimental: MTA Fillapex-Cervical; 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.	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.
Experimental: AH Plus-2mm; 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.	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.
Experimental: MTA Fillapex-2mm; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federal University of Pelotas

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2018
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital; Tooth Discoloration
• Other Study ID Numbers: FUfpel 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No