Clinical trial NCT05221450: Factors Affecting the Endodontic Treatment Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Apical Periodontitis
Apical Granuloma
Apical Cyst
Keywords: root canal treatment
outcome
success
Lead sponsor: Odontos, Specialisticna Zobna Ambulanta, d.o.o.
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
First posted: 2022-02-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment outcome based on strict combined radiographic and clinical criteria
timeFrame: 1-4 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Odontos, specialistična zobna ambulanta, d.o.o.
Study officials:
References:
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.
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.
citation: 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.
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.
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.
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.