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临床试验/NCT04126928
NCT04126928已完成不适用

Validation of PUFA Index in Assessing Untreated Dental Caries Among Malaysian Adult Subpopulation

Universiti Kebangsaan Malaysia Medical Centre1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2015年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
165
试验地点
1
主要终点
PUFA

研究概览

简要总结

PUFA Index was introduced to detect the clinical consequences of untreated dental caries. To date, there are no studies on the reliability and accuracy of the PUFA index as a screening tool. Other than indices, radiographs were sometimes used as a screening tool using the validated Periapical Index (PAI). The aim of this study was to evaluate the reliability and accuracy of PUFA and PAI in screening for clinical outcomes of untreated caries, specifically pulpal and periapical diseases. The reference standard is the clinical diagnosis, as categorized by the American Association of Endodontists. Intra- and inter-examiner reliability will be determined using Cohen's kappa. Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated. Receiver Operating Characteristics (ROC) contrast estimation will be computed to compare the two index tests.

详细描述

The index of decayed-missing-filled permanent teeth (DMFT) records decayed (D), missing (M), or filled (F) teeth in an individual, but it fails to give information about the clinical outcomes of untreated dental caries. A new index complements the DMFT index by recording the advancement of the caries lesion into surrounding tissues, including pulpal involvement (P), ulceration due to tooth fragments (U), fistula formation (F) and abscess (A). The PUFA index has yet to be validated in the adult population. Other than indices, radiographs were sometimes used as a screening tool using the validated Periapical Index (PAI). Hence, the aim of this study is to evaluate the reliability and accuracy of PUFA and PAI in screening for clinical outcomes of untreated caries, specifically pulpal and periapical diseases. The study will be carried out in Primary Care Clinic, Faculty of Dentistry, Universiti Kebangsaan Malaysia. Consecutive sampling will be used; all eligible patients are invited to participate. The inclusion criteria are as follow:

i. New patient, not receiving active dental treatment at the time of study ii. Adult patient (18 years old or above) iii. Having at least 12 teeth in the oral cavity iv. Presented with the clinical situation for which radiograph(s) were indicated v. No radiograph was taken within the last six months The reference standard is the clinical diagnosis, as categorized by the American Association of Endodontists. A comprehensive examination will be carried out for each tooth, followed by investigation using orthopantomography (OPG), periapical radiograph, periodontal probing, heat test, cold test, electric pulp tester when indicated, to aid in arriving at the definitive diagnosis.

Two independent, trained dentists are employed to screen the participants using DMFT and PUFA indices, blinded to the clinical diagnosis and PAI scoring. The examination is done using only a mouth mirror.

Another two independent, trained dentists, blinded to the clinical diagnoses and the PUFA scoring, will score each tooth on the orthopantomograph for the periapical status using the Periapical Index (PAI).

The outcome of PUFA is dichotomized as Positive (PUFA>0) or Negative (PUFA=0) for each tooth. Similarly, the PAI was dichotomized as Positive (PAI≥3) or Negative (PAI<3). Intra- and inter-examiner reliability will be determined using Cohen's kappa. Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated. ROC contrast estimation will be computed to compare the two index tests.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •New patient, not receiving active dental treatment at the time of the study
  • •Adult patient (18 years old or above)
  • •Has at least 12 teeth in the oral cavity
  • •Presented with the clinical situation for which radiograph(s) were indicated (American Dental Association 2012)
  • •No radiograph was taken within the last 6 months

排除标准

  • •Medically compromised (American Society of Anesthesiologists ASA3)

研究组 & 干预措施

Participant

Other

Each participant will go through (i) screening using DMFT and PUFA, (ii) orthopantomography assessment using PAI, and (iii) comprehensive clinical examination to derive pulpal and periapical diagnoses

干预措施: Screening using DMFT and PUFA, orthopantomogram is taken and assessed using PAI, comprehensive clinical examination to diagnose pulpal and periapical conditions. (Diagnostic Test)

结局指标

主要结局

PUFA

时间窗: All variables for each person are collected at one point in time. An average visit is two hours per person.

Pulpal involvement (P), ulceration due to tooth fragments (U), fistula formation (F) and abscess (A), assessed clinically using only mouth mirror

Diagnosis of pulpal and periapical diseases

时间窗: All variables for each person are collected at one point in time. An average visit is two hours per person.

Diagnosis of pulpal and periapical diseases using the diagnostic criteria of American Association of Endodontists following comprehensive clinical examination

DMFT

时间窗: All variables for each person are collected at one point in time. An average visit is two hours per person.

Decayed (D), missing (M), or filled (F) tooth, assessed clinically using only mouth mirror

Periapical Index (PAI)

时间窗: All variables for each person are collected at one point in time. An average visit is two hours per person.

An ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe apical periodontitis), assessed radiographically. Higher scores mean a worse outcome.

次要结局

未报告次要终点

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Liew

Lecturer

Universiti Kebangsaan Malaysia Medical Centre

研究点 (1)

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