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NCT Number: NCT03459638

Periodontitis as Signal for an Underlying Disease

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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Key information

Conditions

Diabetes Mellitus Apnea Cardiovascular Diseases Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nervous System Diseases Nutritional and Metabolic Diseases Obstructive Sleep Apnea Syndrome Periodontal Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Centre for Dentistry Amsterdam

Amsterdam, North Holland, 1081 LA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening for DM, ASCVD, MetS and OSAS

Other

Finger stick analysis, questionnaires and clinical measurements

Primary outcomes

  1. Prevalence of prediabetes and diabetes (DM)

    Time frame: 24 months

    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).

  2. 10-year-risk of atherosclerotic cardiovascular disease (ASCVD)

    Time frame: 24 months

    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%.

  3. Prevalence of metabolic syndrome (MetS)

    Time frame: 24 months

    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).

  4. Risk of obstructive sleep apnea syndrome (OSAS)

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Academic Centre for Dentistry in Amsterdam

Other

Collaborators

  • Labonovum B.V.
  • Netherlands Enterprise Agency
  • Sunstar Suisse S.A.

Registry information

Official study title

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

Acronym: PACMEL

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2018
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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