Periodontitis as Signal for an Underlying Disease (PACMEL)

Academic Centre for Dentistry in Amsterdam

Status

Completed

Conditions

Diabetes Mellitus

Obstructive Sleep Apnea Syndrome

Periodontal Diseases

Cardiovascular Diseases

Treatments

Other: Screening for DM, ASCVD, MetS and OSAS

Study type

Observational

Funder types

Other

Identifiers

NCT03459638

PerioSystemicACTA

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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