Periodontitis as Signal for an Underlying Disease

NCT03459638 | Completed

• 1 other identifier: PerioSystemicACTA
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the differences between subjects with and without periodontitis in: the prevalence of (pre)diabetes mellitus, the risk of atherosclerotic cardiovascular disease, the prevalence of metabolic syndrome and the risk of obstructive sleep apnea syndrome.

Conditions

Diabetes Mellitus; Periodontal Diseases; Cardiovascular Diseases; Obstructive Sleep Apnea Syndrome

Keywords

Screening

Outcome Measures

Primary Outcomes (4)

• Prevalence of prediabetes and diabetes (DM)

  For DM there is the convenient Haemoglobin A1c (HbA1c) level, which is put forward by the American Diabetes Association (ADA) and International Diabetes Federation (IDF) as indicative of the metabolic state: prediabetes (HbA1c: 39-47 mmol/mol) and diabetes (HbA1c: ≥48 mmol/mol).

  24 months

• 10-year-risk of atherosclerotic cardiovascular disease (ASCVD)

  For ASCVD there is the "10-year-risk" chart, based on age, gender, total cholesterol, HDL cholesterol (HDL-C), LDL cholesterol (LDL-C), systolic and diastolic blood pressure, smoking, presence of diabetes and rheumatoid arthritis (according to the NHG standards, which are the European Society of Cardiology guidelines modified to the Dutch population). The 10-year risk of death or disease by ASCVD can be: Low = \<10%, Middle = 10-20%, High = \>20%.

  24 months

• Prevalence of metabolic syndrome (MetS)

  The diagnostic criteria for MetS are based on the waist circumference (WC), triglycerides (TG), HDL-C, hypertension and dysglycemia (according to the NCEP ATP III). Any 3 of these 5 measures constitute diagnosis of metabolic syndrome. The outcome will be: 1. Absence of MetS (when ≤ 2 measures are met for the criteria of MetS) ; 1. Presence of MetS (when ≥ 3 measures are met for the criteria of MetS).

  24 months

• Risk of obstructive sleep apnea syndrome (OSAS)

  For OSAS there is the recently developed OSAS risk questionnaire (Philips questionnaire), which scores patients into a low, high or severe risk category of having OSAS.The outcome will be on a percentage scale, varying from 0-100%. The cut-off point for being classified into the low risk category will be 35% and the cutt-of point for the severe risk category is 55%. Between 35 and 55%, participants are classified as high risk for OSAS.

  24 months

Study Arms (2)

Periodontitis

Screening for DM, ASCVD, MetS and OSAS in patients with periodontitis

Other: Screening for DM, ASCVD, MetS and OSAS

No periodontitis

'Screening for DM, ASCVD, MetS and OSAS in patients without periodontitis

Other: Screening for DM, ASCVD, MetS and OSAS

Interventions

Screening for DM, ASCVD, MetS and OSAS OTHER

Finger stick analysis, questionnaires and clinical measurements

No periodontitis; Periodontitis

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

: In total 200 patients will be included at the Academic Centre for Dentistry Amsterdam (ACTA). The subjects with periodontitis that will be enrolled in this study are referred to the periodontal clinic for diagnosis and treatment of periodontitis. The subjects without periodontitis will be selected among individuals that visit the dental school for regular dental checkups. All subjects will be 40 years and older and are mainly inhabitants from Amsterdam and surrounding areas.

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Age ≥ 40 years
• (Patient) referred for periodontitis
• (Control) visiting the dental school for regular dental check-up without periodontitis
• Able and willing to give written informed consent and comply with the requirements of the study protocol.

You may not qualify if:

• None

Sponsors & Collaborators

• Academic Centre for Dentistry in Amsterdam: lead
• Labonovum B.V.: collaborator
• Sunstar Suisse S.A.: collaborator
• Netherlands Enterprise Agency: collaborator

Study Sites (1)

Academic Centre for Dentistry Amsterdam

Amsterdam, North Holland, 1081 LA, Netherlands

Location

Related Publications (5)

• Teeuw WJ, Kosho MX, Poland DC, Gerdes VE, Loos BG. Periodontitis as a possible early sign of diabetes mellitus. BMJ Open Diabetes Res Care. 2017 Jan 19;5(1):e000326. doi: 10.1136/bmjdrc-2016-000326. eCollection 2017.

  PMID: 28316794 BACKGROUND

• Nibali L, Tatarakis N, Needleman I, Tu YK, D'Aiuto F, Rizzo M, Donos N. Clinical review: Association between metabolic syndrome and periodontitis: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2013 Mar;98(3):913-20. doi: 10.1210/jc.2012-3552. Epub 2013 Feb 5.

  PMID: 23386648 BACKGROUND

• Al-Jewair TS, Al-Jasser R, Almas K. Periodontitis and obstructive sleep apnea's bidirectional relationship: a systematic review and meta-analysis. Sleep Breath. 2015 Dec;19(4):1111-20. doi: 10.1007/s11325-015-1160-8. Epub 2015 Mar 24.

  PMID: 25801281 BACKGROUND

• Friedewald VE, Kornman KS, Beck JD, Genco R, Goldfine A, Libby P, Offenbacher S, Ridker PM, Van Dyke TE, Roberts WC; American Journal of Cardiology; Journal of Periodontology. The American Journal of Cardiology and Journal of Periodontology editors' consensus: periodontitis and atherosclerotic cardiovascular disease. J Periodontol. 2009 Jul;80(7):1021-32. doi: 10.1902/jop.2009.097001.

  PMID: 19563277 BACKGROUND

• Beukers NG, van der Heijden GJ, van Wijk AJ, Loos BG. Periodontitis is an independent risk indicator for atherosclerotic cardiovascular diseases among 60 174 participants in a large dental school in the Netherlands. J Epidemiol Community Health. 2017 Jan;71(1):37-42. doi: 10.1136/jech-2015-206745. Epub 2016 Aug 8.

  PMID: 27502782 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and oral rinse sample

MeSH Terms

Conditions

Diabetes Mellitus; Periodontal Diseases; Cardiovascular Diseases; Sleep Apnea, Obstructive

Interventions

Mass Screening; ETV3 protein, human

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Madeline X. F. Kosho, MSc, DDS

  Academic Centre for Dentistry Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 9, 2018
• Study Start: March 9, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

NL (1)