Clinical trial NCT03459638: Periodontitis as Signal for an Underlying Disease
Official title: Periodontitis as a Potential Early Risk Indicator for Diabetes Mellitus, Atherosclerotic Cardiovascular Disease, Metabolic Syndrome and Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Periodontal Diseases
Cardiovascular Diseases
Obstructive Sleep Apnea Syndrome
Keywords: Screening
Lead sponsor: Academic Centre for Dentistry in Amsterdam
Sponsor class: OTHER
Collaborators: name: Labonovum B.V.
name: Sunstar Suisse S.A.
name: Netherlands Enterprise Agency
First posted: 2018-03-09
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of prediabetes and diabetes (DM)
timeFrame: 24 months
measure: 10-year-risk of atherosclerotic cardiovascular disease (ASCVD)
timeFrame: 24 months
measure: Prevalence of metabolic syndrome (MetS)
timeFrame: 24 months
measure: Risk of obstructive sleep apnea syndrome (OSAS)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Centre for Dentistry Amsterdam
state: Noord-Holland
Study officials:
affiliation: Academic Centre for Dentistry Amsterdam
name: Madeline X. F. Kosho, MSc, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.