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Completed

NCT Number: NCT04126928

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnant
  • Medically compromised (American Society of Anesthesiologists ASA3)

Treatment and study plan

Screening using DMFT and PUFA, orthopantomogram is taken and assessed using PAI, comprehensive clinical examination to diagnose pulpal and periapical conditions.

Diagnostic Test

Primary outcomes

  1. DMFT

    Time frame: 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

  2. PUFA

    Time frame: 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

  3. Periapical Index (PAI)

    Time frame: 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.

  4. Diagnosis of pulpal and periapical diseases

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2019
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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