Clinical Trials Logo

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05202132
Study type Observational
Source The European Research Group on Periodontology (ERGOPerio)
Status Completed
Start date October 1, 2020
Completion date June 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT04712630 - Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft N/A
Recruiting NCT04964167 - Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis Early Phase 1
Recruiting NCT03997552 - NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration N/A
Recruiting NCT03790605 - A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis Phase 3
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Recruiting NCT03997578 - Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Enrolling by invitation NCT04956211 - Periodontal Treatment and Ischemic Stroke N/A
Completed NCT04402996 - Meteorin-like Levels in Individuals With Periodontitis
Active, not recruiting NCT05311657 - Oral Health and Severe COPD
Not yet recruiting NCT05079204 - Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction N/A
Completed NCT02835898 - Epigenetics and Periodontal Treatment Phase 1
Completed NCT02447510 - Growth Factors Release of PRF and PRGF Phase 3
Completed NCT01750528 - Prevalence and Progression of Periodontitis in Ankylosing Spondylitis N/A
Completed NCT02508987 - Obesity and Oxidative Stress in Patients With Different Periodontal Status N/A
Completed NCT02124655 - Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. Phase 4
Active, not recruiting NCT02135952 - Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis Phase 4
Completed NCT04527913 - Interdental Plaque Reduction and Periodontitis N/A
Completed NCT01593540 - Clinical Examination of Metal Free Interdental Brushes Phase 4
Recruiting NCT02131922 - Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control N/A