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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05221450
Other study ID # 0120-402/2019/5
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date December 2028

Study information

Verified date April 2024
Source Odontos, Specialisticna Zobna Ambulanta, d.o.o.
Contact Rok Juric, DMD
Phone +386 1 2323231
Email rok.juric@odontos.si
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date December 2028
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
primary endodontic treatment


Locations

Country Name City State
Slovenia Odontos, specialisticna zobna ambulanta, d.o.o. Ljubljana

Sponsors (2)

Lead Sponsor Collaborator
Odontos, Specialisticna Zobna Ambulanta, d.o.o. University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

References & Publications (6)

European Society of Endodontology. Quality guidelines for endodontic treatment: consensus report of the European Society of Endodontology. Int Endod J. 2006 Dec;39(12):921-30. doi: 10.1111/j.1365-2591.2006.01180.x. — View Citation

Friedman S, Abitbol S, Lawrence HP. Treatment outcome in endodontics: the Toronto Study. Phase 1: initial treatment. J Endod. 2003 Dec;29(12):787-93. doi: 10.1097/00004770-200312000-00001. — View Citation

Ng YL, Mann V, Gulabivala K. A prospective study of the factors affecting outcomes of nonsurgical root canal treatment: part 1: periapical health. Int Endod J. 2011 Jul;44(7):583-609. doi: 10.1111/j.1365-2591.2011.01872.x. Epub 2011 Mar 2. — View Citation

Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10. — View Citation

Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10. — View Citation

Ricucci D, Russo J, Rutberg M, Burleson JA, Spangberg LS. A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):825-42. doi: 10.1016/j.tripleo.2011.08.003. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment outcome based on strict combined radiographic and clinical criteria 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
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