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临床试验/NCT04495270
NCT04495270已完成不适用

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

Lithuanian University of Health Sciences0 个研究点目标入组 128 人开始时间: 2016年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
128
主要终点
The negative treatment outcome

研究概览

简要总结

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.

详细描述

Study sample The study participants were adult patients, admitted for general oral rehabilitation to Vilnius Implantology Center, Lithuania, and referred for treatment to a specialist in endodontics during the period December 2016 - December 2019. A total of 140 patients, with 200 teeth with AP, were invited to participate in the study. Ten patients were excluded according to the inclusion criteria, and 2 patients declined to participate. Finally, 128 patients with 176 teeth with AP, agreed to participate in this study. The mean age of the participants was 46 years, range 18-70 years, (SD =12.3).

The inclusion criteria were as follows:

  • 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 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).

The diagnosis of apical periodontitis was based on the clinical tests of pulp vitality (sensitivity to heat and cold), percussion, palpation, presence of abnormal bite, swelling, caries, sinus tracts, of unstimulated/stimulated pain, and on the radiological findings. A total of 176 teeth (403 root canals) were subjected to endodontic treatment.

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

The negative treatment outcome

时间窗: 24 months

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).

The positive treatment outcome

时间窗: 24 months

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jelena Gudac

Principal Investigator

Lithuanian University of Health Sciences

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