Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer

January 29, 2020 updated by: Giulia Bardini, Cittadella Universitaria
The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a permanent, single or multi-rooted mature tooth
  • clinical diagnosis of irreversible pulpitis
  • diagnosis of apical periodontitis

Exclusion Criteria:

  • subjects with immune-compromised status
  • subjects with an overall poor prognosis for their treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydraulic Sealer Group

The single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer.

Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity.
Procedure: Root Canal Treatment
Active Comparator: Zinc oxide-eugenol Sealer Group
The continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation.
Procedure: Root Canal Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periapical Healing
Time Frame: 4 year
Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2)
4 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tooth survival
Time Frame: 4 year
Success was defined if the tooth was asymptomatic and considered to be functional regardless of its PAI score
4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cittadella Universitaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETEBCB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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