2-year Treatment Outcomes of Teeth Estimated by Means of Periapical and Endodontic Status Scale

NCT04495270 | Completed DMC

• 1 other identifier: BE-2-27
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: Evaluation of endodontic treatment success is largely based on radiographical assessment of anatomical and treatment-related parameters of teeth with apical periodontitis (AP). This study aimed to analyse 2-year treatment outcomes of teeth with AP based on radiographical changes, and to evaluate prognostic validity of Periapical and Endodontic Status Scale (PESS). Materials and Methods: 128 patients (176 teeth) were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location. Strength of associations between these and treatment-related parameters was tested by logistic regression analysis. Predictive validity of PESS was verified by estimating association between treatment risk groups defined at baseline and negative outcome.

Conditions

Periapical Periodontitis; Treatment Outcome

Keywords

Cone-beam computed tomography; Periapical periodontitis; Scale; Treatment outcome

Outcome Measures

Primary Outcomes (2)

• The positive treatment outcome

  Decreased periapical radiolucency, with respect to it's size, or/and relation with anatomical structures, location (respective parameters S, R, and D). Moreover, the unchanged mild severity scores S1, D1, and R1 were regarded as positive outcome as well. The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).

  24 months

• The negative treatment outcome

  Increased/unchanged periapical radiolucency in size, or/and in relation with anatomical structures, or/and in location (respective parameters S, R, and D). By comparing the baseline and the final CBCT images all transition events from the lower to the higher scores and the following unchanged scores were considered as negative treatment outcomes.The minimum value 0 (means better outcome), the maximum value - 3 (means worse outcome).

  24 months

Study Arms (1)

Clinical observation

All study patients were examined by 1 endodontist clinically and radiographically at baseline and after follow up of endodontic treatment.

Diagnostic Test: Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"

Interventions

Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale" DIAGNOSTIC_TEST

Patients were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location.

Clinical observation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study participants were adult patients, admitted for general oral rehabilitation and referred for treatment to a specialist in endodontics

You may qualify if:

• no systemic diseases present;
• at least one tooth with the diagnosis of AP (necrotic pulp and/or filled root canals) present;
• sufficient periodontal support (absence of clinical periodontal inflammation on an anatomically intact or, on a reduced periodontium \[13\] of the teeth indicated for treatment);
• baseline CBCT images available (performed for general oral rehabilitation planning purposes, no earlier than one month prior to endodontic procedures).

You may not qualify if:

• Pregnant women;
• immunosuppressed patient
• patients presenting with un-restorable teeth (e.g., deep root caries lesion, coronal cracks, root fracture)
• with the probing depths \>5 mm around the marginal bone.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 31, 2020
• Study Start: December 20, 2016
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share