Factors Affecting the Endodontic Treatment Outcome

April 7, 2024 updated by: Odontos, Specialisticna Zobna Ambulanta, d.o.o.
The aim of this prospective cohort observational study is: (i) to assess the endodontic treatment outcome in a private specialist endodontic office in Slovenia; (ii) to estimate the effect of various pre-, intra- and postoperative factors onto endodontic treatment outcome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Janja Jan, Prof.
  • Phone Number: +386 1 522 2770

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • Odontos, specialistična zobna ambulanta, d.o.o.
        • Contact:
        • Contact:
          • Janja Jan, Prof.
          • Phone Number: +386 1 5222770
        • Principal Investigator:
          • Rok Juric, DMD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The sample population will include patients who are referred from a general dental practices in Slovenia to a private specialist endodontic practice for endodontic treatment, from the beginning of January 2008 on. All patients will be over 18 years of age at the beginning of the endodontic treatment and will attent a follow-up examination at least 1-4 years after endodontic treatment.

Teeth will not be included in the study if (i) they have preoperative advanced periodontal disease, (ii) prior microsurgical root-end resection was performed, or (iii) the apex / apices of the tooth are not clearly discernible on any of the periapical radiographs.

Teeth will be excluded from the study if (i) they will be extracted for non-endodontic reason or (ii) the patient will not attend a follow-up examination.

Description

Inclusion Criteria:

  • patients referred to the private endodontic specialist office for endodontic treatment
  • written informed consent was obtained prior beginning of the treatment.

Exclusion Criteria:

  • preoperative advanced periodontal disease
  • prior microsurgical root-end resection performed
  • apices of the tooth were not clearly discernible on any of periapical radiographs
  • endodontic treated teeth were extracted for non-endodontic reason
  • the patient did not attend a follow-up examination.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment outcome based on strict combined radiographic and clinical criteria
Time Frame: 1-4 years postoperatively
Successful treatment outcome is defined as an absence of radiographic sign of apical periodontitis (periapical index PAI <= 2) and clinical signs of inflamation (swelling, sinus tract, tenderness to periapical palpation and percussion, pain) on follow-up examination 1-4 years postoperatively
1-4 years postoperatively

Collaborators and Investigators

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

Sponsor

Odontos, Specialisticna Zobna Ambulanta, d.o.o.

Collaborators

University of Ljubljana, Faculty of Medicine

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)

January 1, 2008

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 22, 2022

First Submitted That Met QC Criteria

January 22, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-402/2019/5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

anonymised IPD that uderlie the results in the publication will we shared to other researcher on reasonable request

IPD Sharing Time Frame

anonymised data will be available on request for 1 year after the publication of the study report

IPD Sharing Access Criteria

contacting the principal investigator by e-mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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