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

NCT04126928 | Completed

• 1 other identifier: UKM 1.5.3.5/244/DD/2015/008(2)
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulpitis; Apical Periodontitis

Keywords

orthopantomograph; periapical index; reliability; sensitivity; specificity

Outcome Measures

Primary Outcomes (4)

• DMFT

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

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

• PUFA

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

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

• Periapical Index (PAI)

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

  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

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

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

Study Arms (1)

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

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

Interventions

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

Participant

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia

Kuala Lumpur, 50300, Malaysia

Location

Related Publications (3)

• Glickman GN. AAE Consensus Conference on Diagnostic Terminology: background and perspectives. J Endod. 2009 Dec;35(12):1619-20. doi: 10.1016/j.joen.2009.09.029. No abstract available.

  PMID: 19932336 BACKGROUND

• Monse B, Heinrich-Weltzien R, Benzian H, Holmgren C, van Palenstein Helderman W. PUFA--an index of clinical consequences of untreated dental caries. Community Dent Oral Epidemiol. 2010 Feb;38(1):77-82. doi: 10.1111/j.1600-0528.2009.00514.x. Epub 2009 Dec 7.

  PMID: 20002630 BACKGROUND

• Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.

  PMID: 3457698 BACKGROUND

MeSH Terms

Conditions

Pulpitis; Periapical Periodontitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Immune System Diseases

Study Officials

• Dalia Abdullah, MClinDent

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 15, 2019
• Study Start: September 10, 2015
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)