Masticatory Function in the Differential Diagnosis of Stage IV Periodontitis

NCT05202132 | Completed

• 1 other identifier: UW20-637
• Study Type: observational
• Target: 214
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

periodontitis; Screening; diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Area under the receiver operating curve (AUROC)

  Baseline

Interventions

Questionnaire DIAGNOSTIC_TEST

A 3 item validated questionnaire assessing masticatory function

Chewing gum test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Convenience, quota sample (equal number of subjects with stage I, II, III and IV periodontitis) of consecutive patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital

You may qualify if:

• Periodontitis subjects reporting for care at reception clinic of dental hospital

You may not qualify if:

• presence of temporomandibular disorders,
• subjects undergoing orthodontic treatment
• less than 12 teeth;
• subjects having received periodontal treatment in the previous 12 months;
• subjects having received antibiotic medication in the previous 3 months

Sponsors & Collaborators

• The European Research Group on Periodontology (ERGOPerio): lead
• The University of Hong Kong: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (2)

Prince Philip Dental Hospital, the Univerisity of Hong Kong

Hong Kong, China

Location

Faculty of Dentistry, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maurizio Tonetti, DMD

  The European Research Group on Periodontology (ERGOPerio)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 21, 2022
• Study Start: October 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); CN (1)