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Masticatory Function in the Differential Diagnosis of Stage IV Periodontitis

NCT05202132 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2022-01-21

No results posted yet for this study

Summary

This is a pilot diagnostic accuracy study to assess the ability to discriminate in a screening context Stage IV periodontitis from other stages of periodontitis. The index test is the assessment of masticatory dysfunction performed with a questionnaire and a chewing gum test. The reference standard is a full periodontal and functional assessment performed by a trained and calibrated specialist.

Conditions

  • Periodontitis

Interventions

DIAGNOSTIC_TEST

Questionnaire

A 3 item validated questionnaire assessing masticatory function

DIAGNOSTIC_TEST

Chewing gum test

The test is based on the ability of a subject of mixing a two colour chewing gum with 20 masticatory cycles. Mixing of the two colour chewing gum will be assessed as variance of hue in a scanned image of the flattened chewing gum. The method has been validated in independent studies.

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    collaborator OTHER

  • The European Research Group on Periodontology (ERGOPerio)

    lead NETWORK

Principal Investigators

  • Maurizio Tonetti, DMD · The European Research Group on Periodontology (ERGOPerio)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-05-31
Completion
2021-06-30

Countries

  • China
  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202132 on ClinicalTrials.gov