Periodontitis as Signal for an Underlying Disease

Cardiovascular Diseases Clinical Trial

— PACMEL  

Official title:

Periodontitis as a Potential Early Risk Indicator for Diabetes Mellitus, Atherosclerotic Cardiovascular Disease, Metabolic Syndrome and Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459638
• Other study ID #: PerioSystemicACTA
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2023
• Source: Academic Centre for Dentistry in Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Diabetes Mellitus (DM), Atherosclerotic Cardiovascular Disease (ASCVD), Metabolic Syndrome (MetS) and Obstructive Sleep Apnea Syndrome (OSAS) are major health problems. However due to absence of symptoms and/or lack of knowledge, people are often unaware of having DM, ASCVD, MetS or OSAS while early treatment could prevent or stop the progression of these diseases. Therefore risk indicators for early detection of DM, ASCVD, MetS and OSAS are needed and proposed.

Many studies demonstrate the association between oral diseases and DM and/or ASCVD. The most observed chronic oral disease is periodontitis. Periodontitis is a common chronic multifactorial inflammatory disease of the supporting structures of the teeth. DM and ASCVD might, due to their proinflammatory state and alteration of the immune system, contribute to the onset and/or progression of periodontitis. Therefore periodontitis could be considered as an early sign of an underlying vascular and/or metabolic pathology.

Some studies have also reported a positive association between periodontitis and MetS. The MetS prevalence in patients with periodontitis was shown to be higher than controls and MetS showed to be associated with severe periodontitis. The association between periodontitis and OSAS is less established, however there is some evidence to a plausible association between periodontal disease and Obstructive Sleep Apnea (OSA).

Due to the broad overlap of objective biomarkers, in this study, subjects with or without periodontitis will be screened for determining the prevalence of (pre)DM, the 10 year risk of ASCVD, the prevalence of MetS and the risk of OSAS.

The screening will be based on clinical measures, specific blood markers determined by a developed finger stick procedure and three questionnaires.

Notably, a recently published pilot paper from the ACTA periodontology research group presents the feasibility and preliminary results of proposed screening for (pre)DM; 18.1% new DM cases were found among subjects with severe periodontitis, compared to 9.9% in mild/moderate periodontitis and 8.5% in controls.

Objective of the study:

The aim of the proposed study is to screen for (pre)DM, an increased 10 year risk of ASCVD, MetS and a high risk of OSAS in participants with and without periodontitis. Consequently, the dental office will be evaluated as a suitable location for early detection of these diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Obstructive Sleep Apnea Syndrome
• Periodontal Diseases
• Periodontitis
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Other:
• Screening for DM, ASCVD, MetS and OSAS
Finger stick analysis, questionnaires and clinical measurements

Locations

Country	Name	City	State
Netherlands	Academic Centre for Dentistry Amsterdam	Amsterdam	Noord-Holland

Sponsors (4)

Lead Sponsor	Collaborator
Academic Centre for Dentistry in Amsterdam	Labonovum B.V., Netherlands Enterprise Agency, Sunstar Suisse S.A.

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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