Diagnostic Accuracy of Rapid Non-clinical Screening Tests for Early Detection of Periodontitis

NCT03928080 | Completed

• 2 other identifiers: PhD20190130HKUCTR-2631
• Study Type: observational
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

Gum disease is the 6th most prevalent disease of mankind. It is a non-communicable non-resolving inflammation; if untreated it leads to tooth loss and inability to chew properly. It is one of the top 80 human disease contributing 3.5 million years lived with disability and the major cause of increasing oral health costs. Addressing this major public health problem requires greater attention to prevention and early detection. Gum disease cases in the population remain largely undetected because an affected individual does not feel the presence of gum disease and as a consequence people seek attention in the later stages of the disease once tooth loss has occurred. In this study the investigators will compare different methods of screening for gum disease and compare them against a full professional examination. The investigators hope to be able to propose simple and effective methods for self-assessment that will allow people to suspect the presence of the disease before tooth loss occurs and thus allow early diagnosis and better treatment. The whole study procedures consist 3 screening tests and the standard clinical examination. The screening tests involves:(1) a screening questionnaire; (2) a saliva test; (3) a toothbrushing test. Thereafter the participants will receive a standard clinical examination which is regarded as the gold standard for diagnosis of gum disease. Results of these tests will be compared with the standard clinical examination to assess the diagnostic accuracy of these tests. The general aim of this program is to improve early detection of periodontitis in the population using a self-detection approach based on a toothbrush test as an early sign and a self-performed saliva test as a screening test for an individual to seek professional dental care early in the gum disease process. The general hypothesis is that combining self-assessment of toothbrush test with a saliva test as an assessment of key inflammatory process underlying gum disease will increase the diagnostic accuracy of a screening approach in the population.

Conditions

Periodontitis; Gingivitis

Keywords

diagnostic accuracy; early detection; self-assessment; periodontitis

Outcome Measures

Primary Outcomes (4)

• Sensitivity measure

  Sensitivity of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination

  1day

• Specificity measure

  Specificity of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination

  1day

• The area under the receiver operating characteristic curve (AUC) measure

  The area under the receiver operating characteristic curve (AUC) of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination

  1day

• The post-test probability measure

  The post-test probability of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination

  1day

Study Arms (2)

Experimental cohort

Primary study to assess diagnostic accuracy

Diagnostic Test: Bleeding on brushing

Confirmation cohort

Second cohort to confirm results from the first study on independent population

Diagnostic Test: Bleeding on brushing

Interventions

Bleeding on brushing DIAGNOSTIC_TEST

Index tests are bleeding on brushing and aMMP-8 Gold standard: clinical diagnosis performed by specialist

Also known as: aMMP-8

Confirmation cohort; Experimental cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

a convenience sample of consecutive untreated subjects seeking dental care at Prince Philip Dental Hospital

You may qualify if:

• Aged 18 and above.
• Having the ability to learn the standard toothbrushing method with artificial intelligence powered toothbrush.
• Ability and willingness to give written informed consent.

You may not qualify if:

• Edentulous mouth.
• Pregnant females.
• Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months.
• Having received antibiotic medication within the previous 3 months.

Sponsors & Collaborators

• The European Research Group on Periodontology (ERGOPerio): lead
• The University of Hong Kong: collaborator

Study Sites (1)

Prince Philip Dental Hospital, the Univerisity of Hong Kong

Hong Kong, China

Location

Related Publications (15)

• Blicher B, Joshipura K, Eke P. Validation of self-reported periodontal disease: a systematic review. J Dent Res. 2005 Oct;84(10):881-90. doi: 10.1177/154405910508401003.

  PMID: 16183785 RESULT

• Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.

  PMID: 26511519 RESULT

• Carra MC, Gueguen A, Thomas F, Pannier B, Caligiuri G, Steg PG, Zins M, Bouchard P. Self-report assessment of severe periodontitis: Periodontal screening score development. J Clin Periodontol. 2018 Jul;45(7):818-831. doi: 10.1111/jcpe.12899. Epub 2018 May 16.

  PMID: 29611224 RESULT

• Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Beck JD, Taylor GW, Borgnakke WS, Page RC, Genco RJ. Self-reported measures for surveillance of periodontitis. J Dent Res. 2013 Nov;92(11):1041-7. doi: 10.1177/0022034513505621. Epub 2013 Sep 24.

  PMID: 24065636 RESULT

• Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.

  PMID: 24582925 RESULT

• Izadi Borujeni S, Mayer M, Eickholz P. Activated matrix metalloproteinase-8 in saliva as diagnostic test for periodontal disease? A case-control study. Med Microbiol Immunol. 2015 Dec;204(6):665-72. doi: 10.1007/s00430-015-0413-2. Epub 2015 Apr 5.

  PMID: 25841875 RESULT

• Kallio P, Ainamo J, Dusadeepan A. Self-assessment of gingival bleeding. Int Dent J. 1990 Aug;40(4):231-6.

  PMID: 2397955 RESULT

• Kallio P. Self-assessed bleeding in monitoring gingival health among adolescents. Community Dent Oral Epidemiol. 1996 Apr;24(2):128-32. doi: 10.1111/j.1600-0528.1996.tb00829.x.

  PMID: 8654034 RESULT

• Leppilahti JM, Ahonen MM, Hernandez M, Munjal S, Netuschil L, Uitto VJ, Sorsa T, Mantyla P. Oral rinse MMP-8 point-of-care immuno test identifies patients with strong periodontal inflammatory burden. Oral Dis. 2011 Jan;17(1):115-22. doi: 10.1111/j.1601-0825.2010.01716.x.

  PMID: 20659259 RESULT

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 RESULT

• Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S46-S73. doi: 10.1002/JPER.17-0576.

  PMID: 29926936 RESULT

• Bi M, Xie Y, Yu X, Li H, Pelekos G, Jin L, Li Y, Tonetti MS. Clinical Features Associated With Periodontal Case Misclassification by an Active Matrix Metalloproteinase-8 Point-of-Care Oral Rinse Test. J Clin Periodontol. 2025 Sep;52(9):1276-1287. doi: 10.1111/jcpe.14189. Epub 2025 Jun 3.

  PMID: 40462486 DERIVED

• Deng K, Zonta F, Yang H, Pelekos G, Tonetti MS. Development of a machine learning multiclass screening tool for periodontal health status based on non-clinical parameters and salivary biomarkers. J Clin Periodontol. 2024 Dec;51(12):1547-1560. doi: 10.1111/jcpe.13856. Epub 2023 Sep 11.

  PMID: 37697491 DERIVED

• Uy SNMR, Deng K, Fok CTC, Fok MR, Pelekos G, Tonetti MS. Food intake, masticatory function, tooth mobility, loss of posterior support, and diminished quality of life are associated with more advanced periodontitis stage diagnosis. J Clin Periodontol. 2022 Mar;49(3):240-250. doi: 10.1111/jcpe.13588. Epub 2022 Jan 20.

  PMID: 34935175 DERIVED

• Deng K, Pelekos G, Jin L, Tonetti MS. Gingival bleeding on brushing as a sentinel sign of gingival inflammation: A diagnostic accuracy trial for the discrimination of periodontal health and disease. J Clin Periodontol. 2021 Dec;48(12):1537-1548. doi: 10.1111/jcpe.13545. Epub 2021 Oct 4.

  PMID: 34494292 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and mouth rinse

MeSH Terms

Conditions

Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Maurizio Tonetti, DMD,PhD,MMSc

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 25, 2019
• Study Start: September 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)