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

Primary Purpose

Pulpitis, Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Screening using DMFT and PUFA, orthopantomogram is taken and assessed using PAI, comprehensive clinical examination to diagnose pulpal and periapical conditions.
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulpitis focused on measuring orthopantomograph, periapical index, reliability, sensitivity, specificity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Universiti Kebangsaan Malaysia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Participant

Arm Description

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

Outcomes

Primary Outcome Measures

DMFT
Decayed (D), missing (M), or filled (F) tooth, assessed clinically using only mouth mirror
PUFA
Pulpal involvement (P), ulceration due to tooth fragments (U), fistula formation (F) and abscess (A), assessed clinically using only mouth mirror
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.
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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2019
Last Updated
October 14, 2019
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04126928
Brief Title
Validation of PUFA Index in Assessing Untreated Dental Caries Among Malaysian Adult Subpopulation
Official Title
Validation of PUFA Index in Assessing Untreated Dental Caries Among Malaysian Adult Subpopulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 10, 2015 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis, Apical Periodontitis
Keywords
orthopantomograph, periapical index, reliability, sensitivity, specificity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participant
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening using DMFT and PUFA, orthopantomogram is taken and assessed using PAI, comprehensive clinical examination to diagnose pulpal and periapical conditions.
Primary Outcome Measure Information:
Title
DMFT
Description
Decayed (D), missing (M), or filled (F) tooth, assessed clinically using only mouth mirror
Time Frame
All variables for each person are collected at one point in time. An average visit is two hours per person.
Title
PUFA
Description
Pulpal involvement (P), ulceration due to tooth fragments (U), fistula formation (F) and abscess (A), assessed clinically using only mouth mirror
Time Frame
All variables for each person are collected at one point in time. An average visit is two hours per person.
Title
Periapical Index (PAI)
Description
An ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe apical periodontitis), assessed radiographically. Higher scores mean a worse outcome.
Time Frame
All variables for each person are collected at one point in time. An average visit is two hours per person.
Title
Diagnosis of pulpal and periapical diseases
Description
Diagnosis of pulpal and periapical diseases using the diagnostic criteria of American Association of Endodontists following comprehensive clinical examination
Time Frame
All variables for each person are collected at one point in time. An average visit is two hours per person.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia Abdullah, MClinDent
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia
City
Kuala Lumpur
ZIP/Postal Code
50300
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19932336
Citation
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.
Results Reference
background
PubMed Identifier
20002630
Citation
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.
Results Reference
background
PubMed Identifier
3457698
Citation
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.
Results Reference
background

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

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