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NCT04126928
Validation of PUFA Index in Assessing Untreated Dental Caries Among Malaysian Adult Subpopulation
NA trial testing Screening using DMFT and PUFA, orthopantomogram is taken and assessed using PAI, comprehensive clinical examination to diagnose pulpal and periapical conditions. in Pulpitis in 165 participants. Completed in 29 January 2018.
29 January 2018
Quick facts
| Lead sponsor | Universiti Kebangsaan Malaysia Medical Centre |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 165 |
| Start date | 10 September 2015 |
| Primary completion | 29 January 2018 |
| Estimated completion | 29 January 2018 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Screening using DMFT and PUFA, orthopantomogram is taken and assessed using PAI, comprehensive clinical examination to diagnose pulpal and periapical conditions.
Conditions studied
- Pulpitis — all drugs for Pulpitis →
- Apical Periodontitis — all drugs for Apical Periodontitis →
Sponsor
Universiti Kebangsaan Malaysia Medical Centre — full company profile →
Who can join
18 and older, any sex, with Pulpitis or Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04126928
- Europe PMC full search
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Related trials
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Other Universiti Kebangsaan Malaysia Medical Centre trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04126928 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiti Kebangsaan Malaysia Medical Centre
- Last refreshed: 15 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04126928.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing