Factors Affecting the Endodontic Treatment Outcome

Sponsor
Odontos, Specialisticna Zobna Ambulanta, d.o.o. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05221450
Collaborator
University of Ljubljana, Faculty of Medicine (Other)
700
1
191
3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: primary endodontic treatment

Study Design

Study Type:
Observational
Anticipated Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Actual Study Start Date :
Jan 1, 2008
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Treatment outcome based on strict combined radiographic and clinical criteria [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Odontos, specialistična zobna ambulanta, d.o.o. Ljubljana Slovenia 1000

Sponsors and Collaborators

  • Odontos, Specialisticna Zobna Ambulanta, d.o.o.
  • University of Ljubljana, Faculty of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Odontos, Specialisticna Zobna Ambulanta, d.o.o.
ClinicalTrials.gov Identifier:
NCT05221450
Other Study ID Numbers:
  • 0120-402/2019/5
First Posted:
Feb 3, 2022
Last Update Posted:
Feb 3, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Odontos, Specialisticna Zobna Ambulanta, d.o.o.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2022