Masticatory Function in the Differential Diagnosis of Stage IV Periodontitis

Periodontitis Clinical Trial

Official title:

Pilot Study on the Accuracy of Masticatory Function Assessment to Discriminate Stage IV Periodontitis From Other Periodontitis Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05202132
• Other study ID #: UW20-637
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2022
• Source: The European Research Group on Periodontology (ERGOPerio)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a pilot diagnostic accuracy study. Data are derived from a cross-sectional study based on a convenience, quota sample of patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital or at the Institute of Advanced Dentistry, the University of Hong Kong between October 2020 and May 2021. The study will be conducted in accordance with the current revision of the Declaration of Helsinki. Informed consent will be obtained from all participants prior to enrollment in the study. This study will follow the Standards for Reporting Diagnostic Accuracy (STARD) guidelines. To limit bias, separate calibrated examiners performed the index test (chewing gum test) and the periodontal examination used for periodontitis stage and grade diagnosis (reference standard).

To evaluate the diagnostic accuracy of masticatory function assessment for Stage IV periodontitis, logistic regression analyses will be conducted in univariate analyses and the area under the receiver operating characteristic curve (AUROC), diagnostic odds ratios (DORs), sensitivity, specificity, positive predictive values and negative predictive values will be calculated.

Multivariate logistic regression models will be applied to develop a screening algorithm for Stage IV periodontitis diagnosis including the masticatory function assessment and other candidate predictors. A backward stepwise selection method will be used (p = 0.05 for inclusion in model; p = 0.05 for removal from model). The standard nomenclature for interpreting low, moderate and high levels of accuracy will be based on sensitivity and specificity as well as the AUROC values: low level = sensitivity or specificity <60%, AUROC ≤ 0.70; moderate level = sensitivity or specificity ranging from 60% to 79%, AUROC ranging from 0.71 to 0.90; high level = sensitivity or specificity ≥ 80%, AUROC>0.90

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Diagnostic Test:
• Questionnaire
A 3 item validated questionnaire assessing masticatory function
• 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.

Locations

Country	Name	City	State
China	Prince Philip Dental Hospital, the Univerisity of Hong Kong	Hong Kong
Hong Kong	Faculty of Dentistry, The University of Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The European Research Group on Periodontology (ERGOPerio)	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, The University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Area under the receiver operating curve (AUROC)	Baseline