Factors Affecting the Endodontic Treatment Outcome

NCT05221450 | Recruiting

• 1 other identifier: 0120-402/2019/5
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Apical Periodontitis; Apical Granuloma; Apical Cyst

Keywords

root canal treatment; outcome; success

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

primary endodontic treatment PROCEDURE

Also known as: secondary endodontic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Odontos, specialistična zobna ambulanta, d.o.o.

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (6)

• 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.

  PMID: 21366626 BACKGROUND

• 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.

  PMID: 14686806 BACKGROUND

• 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.

  PMID: 17180780 BACKGROUND

• 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.

  PMID: 17931389 BACKGROUND

• 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.

  PMID: 17931388 BACKGROUND

• 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.

  PMID: 22099859 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Periapical Granuloma; Radicular Cyst

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Cyst; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Musculoskeletal Diseases

Central Study Contacts

Rok Juric, DMD

CONTACT

+386 1 2323231; rok.juric@odontos.si

Janja Jan, Prof.

CONTACT

+386 1 522 2770

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 3, 2022
• Study Start: January 1, 2008
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: anonymised data will be available on request for 1 year after the publication of the study report
• Access Criteria: contacting the principal investigator by e-mail

Locations

SL (1)