Periodontitis as Signal for an Underlying Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-09

Study Completion Date

2020-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Periodontal Diseases Cardiovascular Diseases Obstructive Sleep Apnea Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Periodontitis

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

Screening for DM, ASCVD, MetS and OSAS

Intervention Type OTHER

Finger stick analysis, questionnaires and clinical measurements

No periodontitis

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

Screening for DM, ASCVD, MetS and OSAS

Intervention Type OTHER

Finger stick analysis, questionnaires and clinical measurements

Interventions

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Screening for DM, ASCVD, MetS and OSAS

Finger stick analysis, questionnaires and clinical measurements

Intervention Type OTHER

Eligibility Criteria

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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.