Treatment Outcome Clinical Trial
Official title:
Two-year Treatment Outcomes of Teeth With Apical Periodontitis Based on Cone-beam Computed Tomography and Estimated by Means of Periapical and Endodontic Status Scale
NCT number | NCT04495270 |
Other study ID # | BE-2-27 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 20, 2016 |
Est. completion date | December 20, 2019 |
Verified date | July 2020 |
Source | Lithuanian University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lithuanian University of Health Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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