Diabetes MellitusPACMELNCT03459638
Periodontitis as Signal for an Underlying Disease
An observational study of Diabetes Mellitus and Periodontal Diseases, run by Academic Centre for Dentistry in Amsterdam at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Periodontal Diseases, Cardiovascular Diseases
- What is being tested?
- Screening for DM, ASCVD, MetS and OSAS
- How many people
- 105 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Mar 2018to 1 Apr 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Centre for Dentistry Amsterdam
Amsterdam, North Holland, 1081 LA
About this study
Official title: Periodontitis as a Potential Early Risk Indicator for Diabetes Mellitus, Atherosclerotic Cardiovascular Disease, Metabolic Syndrome and Obstructive Sleep Apnea Syndrome
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Periodontal Diseases, Cardiovascular Diseases, Obstructive Sleep Apnea Syndrome
- Being tested
- Screening for DM, ASCVD, MetS and OSAS
- Keywords
- Screening
- Medical subject headings
- Diabetes Mellitus, Periodontal Diseases, Cardiovascular Diseases, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for DM, ASCVD, MetS and OSASOther
Finger stick analysis, questionnaires and clinical measurements
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Screening for DM, ASCVD, MetS and OSAS in patients with periodontitis Receives: Other: Screening for DM, ASCVD, MetS and OSAS | |
| No periodontitis | 'Screening for DM, ASCVD, MetS and OSAS in patients without periodontitis Receives: Other: Screening for DM, ASCVD, MetS and OSAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
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%.
Measured: 24 months
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).
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start9 Mar 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Academic Centre for Dentistry in Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Labonovum B.V., Sunstar Suisse S.A., Netherlands Enterprise Agency
- Responsible party
- Principal investigator, M. X. F. Kosho, Academic Centre for Dentistry in Amsterdam
- Investigators
- Madeline X. F. Kosho, MSc, DDS, Principal investigator, Academic Centre for Dentistry Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459638
- Sponsor's protocol ID
- PerioSystemicACTA
- Acronym
- PACMEL
- Status last verified
- Feb 2023
- First submitted
- 2 Mar 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28316794Nibali 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.
PubMed 23386648Al-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.
PubMed 25801281Friedewald 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.
PubMed 19563277Beukers 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.
PubMed 27502782
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontitis as a Potential Early Risk Indicator for Diabetes Mellitus, Atherosclerotic Cardiovascular Disease, Metabolic Syndrome and Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT03459638
- Acronym / sponsor ID
- PACMEL / PerioSystemicACTA
- Conditions
- Diabetes Mellitus, Periodontal Diseases, Cardiovascular Diseases, Obstructive Sleep Apnea Syndrome
- Keywords
- Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Academic Centre for Dentistry in AmsterdamUniversity, hospital or other
- Collaborators
- Labonovum B.V., Sunstar Suisse S.A., Netherlands Enterprise Agency
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | Other: Screening for DM, ASCVD, MetS and OSASScreening for DM, ASCVD, MetS and OSAS in patients with periodontitis |
| No periodontitis | – | Other: Screening for DM, ASCVD, MetS and OSAS'Screening for DM, ASCVD, MetS and OSAS in patients without periodontitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for DM, ASCVD, MetS and OSASFinger stick analysis, questionnaires and clinical measurements | Other | No periodontitis, Periodontitis |
Primary outcome
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).
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%.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 28316794Teeuw 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.
- Background: PubMed 23386648Nibali 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.
- Background: PubMed 25801281Al-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.
- Background: PubMed 19563277Friedewald 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.
- Background: PubMed 27502782Beukers 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madeline X. F. Kosho, MSc, DDS principal investigator
Academic Centre for Dentistry Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Periodontal Diseases, run by Academic Centre for Dentistry in Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of prediabetes and diabetes (DM) (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03459638, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.