PeriodontitisPlanPerioMedNCT05574231
A Danish Nationwide Longitudinal Study on Prevalence of Periodontitis and Its Co-morbidities
An observational study of Periodontitis and Diabetes Mellitus, Type 2, run by University of Copenhagen.
Trial summary
The project (PlanPerioMed) is a register-based study evaluating the associations and patterns of health care delivery between periodontitis and medical diseases using data from the Danish dental record system Dentalsuite (Plandent A/S) and national Danish health care registries with three overall hypotheses/ aims… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Periodontitis, Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 4,000,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to 31 Dec 2025
- How long will I take part?
- 25 Years
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include people who are clinically diagnosed with periodontal diseases and private practice dental care attenders in Denmark.
Who may be able to join
- Subjects with clinical registrations of DMFT, periodontal status and corresponding treatment codes
- Self-reported systemic diseases including Diabetes Mellitus Type 2, Cardiovascular Diseases and Rheumatoid Arthritis
- Subjects with Clinical Attachment Loss>=3mm, Probing Depth >= 3mm and bleeding on probing (as defined by World Workshop 2017- criteria for periodontitis) in clinical examination will be included in the study population.
Who cannot join
- Subjects with more than 32 teeth
- Subjects with no clinical registrations
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Danish Nationwide Longitudinal Registered Based Study on Prevalence, Treatment Patterns and Disease Trajectories of Periodontitis and Co-morbidities 'PlanPerioMed'
The project (PlanPerioMed) is a register-based study evaluating the associations and patterns of health care delivery between periodontitis and medical diseases using data from the Danish dental record system Dentalsuite (Plandent A/S) and national Danish health care registries with three overall hypotheses/ aims:
- Determine the extent to which periodontitis in registry data is associated with more odontological treatment services and treatment frequency.
- Determine if patients with systemic diseases attend dentists more frequently and receive more treatment services per patient than the population without these diseases.
- Determine to which extent periodontitis and received periodontal treatment affects the risk of medical diseases.
The study will focus on association and trajectories of periodontitis and its treatment with three medical diseases, namely, Type 2 Diabetes Mellitus (Type 2 DM), Cardiovascular Diseases (CVD) and Rheumatoid Arthritis (RA). The dataset consists of approximately 4,000,000 people aged between 18 and 99 years attending private practice in Denmark. The results from PlanPerioMed study are likely to have ramifications for treatment guidelines for other periodontitis comorbidities, e.g. CVD and DM, and will thereby improve the quality of life for a wide range of patients and reduce long-term societal health care expenses related to periodontitis and its comorbidities.
- Being tested
- Periodontal treatment
- Keywords
- Periodontal Diseases, Periodontal Index, Periodontal Bone Loss, Periodontal Attachment Loss, Probing Depth, Bleeding on Probing, Clinical Attachment Loss, Diabetes Mellitus 2, DM type 2, Non-insulin dependent diabetes mellitus, Uncontrolled diabetes mellitus type 2, Increased blood glucose level, CVD, Cardiovascular risk, Heart disease, Heart disease risk factors, Smoking status, Socio-economic status, Register based, Longitudinal study, Danish nationwide study, systemic diseases
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Arthritis, Rheumatoid, Periodontal Diseases, Alveolar Bone Loss, Periodontal Attachment Loss, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
It includes surgical and non-surgical procedures depending on patient as well as tooth level.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment frequency and type of treatment services
Number of treatment and odontological treatment services due to periodontitis
Measured: 25 years
Treatment frequency and type of treatment services among patients with medical diseases
Number of treatment and odontological treatment services among patients with medical diseases due to periodontitis
Measured: 25 years
Effect on medical diseases
Risk of medical diseases based on periodontal disease extent and received periodontal treatment
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 4,000,000 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Plandent A/S
- Responsible party
- Principal investigator, Christian Damgaard, University of Copenhagen
- Investigators
- Anne Havemose Poulsen, Study director, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574231
- Sponsor's protocol ID
- 522-0018/22-3800
- Other IDs
- 522-0018/22-3800
- Acronym
- PlanPerioMed
- Status last verified
- Oct 2022
- First submitted
- 1 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kongstad J, Ekstrand K, Qvist V, Christensen LB, Cortsen B, Gronbaek M, Holm-Pedersen P, Holmstrup P, Bardow A, Twetman S, Fiehn NE. Findings from the oral health study of the Danish Health Examination Survey 2007-2008. Acta Odontol Scand. 2013 Nov;71(6):1560-9. doi: 10.3109/00016357.2013.776701. Epub 2013 Apr 29.
PubMed 23627881Kongstad J, Enevold C, Christensen LB, Fiehn NE, Holmstrup P. Impact of Periodontitis Case Criteria: A Cross-Sectional Study of Lifestyle. J Periodontol. 2017 Jun;88(6):602-609. doi: 10.1902/jop.2017.160426. Epub 2017 Jan 27.
PubMed 28128681Hansen GM, Egeberg A, Holmstrup P, Hansen PR. Relation of Periodontitis to Risk of Cardiovascular and All-Cause Mortality (from a Danish Nationwide Cohort Study). Am J Cardiol. 2016 Aug 15;118(4):489-93. doi: 10.1016/j.amjcard.2016.05.036. Epub 2016 May 30.
PubMed 27372888Holmstrup P, Damgaard C, Olsen I, Klinge B, Flyvbjerg A, Nielsen CH, Hansen PR. Comorbidity of periodontal disease: two sides of the same coin? An introduction for the clinician. J Oral Microbiol. 2017 Jun 14;9(1):1332710. doi: 10.1080/20002297.2017.1332710. eCollection 2017.
PubMed 28748036Hansen PR, Holmstrup P. Cardiovascular Diseases and Periodontitis. Adv Exp Med Biol. 2022;1373:261-280. doi: 10.1007/978-3-030-96881-6_14.
PubMed 35612803Joseph R, Rajappan S, Nath SG, Paul BJ. Association between chronic periodontitis and rheumatoid arthritis: a hospital-based case-control study. Rheumatol Int. 2013 Jan;33(1):103-9. doi: 10.1007/s00296-011-2284-1. Epub 2012 Jan 7.
PubMed 22228465
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Danish Nationwide Longitudinal Registered Based Study on Prevalence, Treatment Patterns and Disease Trajectories of Periodontitis and Co-morbidities 'PlanPerioMed'
- ClinicalTrials.gov ID
- NCT05574231
- Acronym / sponsor ID
- PlanPerioMed / 522-0018/22-3800
- Keywords
- Periodontal Diseases, Periodontal Index, Periodontal Bone Loss, Periodontal Attachment Loss, Probing Depth, Bleeding on Probing, Clinical Attachment Loss, Diabetes Mellitus 2, DM type 2, Non-insulin dependent diabetes mellitus, Uncontrolled diabetes mellitus type 2, Increased blood glucose level, CVD, Cardiovascular risk, Heart disease, Heart disease risk factors, Smoking status, Socio-economic status, Register based, Longitudinal study, Danish nationwide study, systemic diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000,000 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Plandent A/S
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Oct 2022 (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.
The project (PlanPerioMed) is a register-based study evaluating the associations and patterns of health care delivery between periodontitis and medical diseases using data from the Danish dental record system Dentalsuite (Plandent A/S) and national Danish health care registries with three overall hypotheses/ aims:
- Determine the extent to which periodontitis in registry data is associated with more odontological treatment services and treatment frequency.
- Determine if patients with systemic diseases attend dentists more frequently and receive more treatment services per patient than the population without these diseases.
- Determine to which extent periodontitis and received periodontal treatment affects the risk of medical diseases.
The study will focus on association and trajectories of periodontitis and its treatment with three medical diseases, namely, Type 2 Diabetes Mellitus (Type 2 DM), Cardiovascular Diseases (CVD) and Rheumatoid Arthritis (RA). The dataset consists of approximately 4,000,000 people aged between 18 and 99 years attending private practice in Denmark. The results from PlanPerioMed study are likely to have ramifications for treatment guidelines for other periodontitis comorbidities, e.g. CVD and DM, and will thereby improve the quality of life for a wide range of patients and reduce long-term societal health care expenses related to periodontitis and its comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 25 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include people who are clinically diagnosed with periodontal diseases and private practice dental care attenders in Denmark.
Key inclusion criteria (3 listed)
- Subjects with clinical registrations of DMFT, periodontal status and corresponding treatment codes
- Self-reported systemic diseases including Diabetes Mellitus Type 2, Cardiovascular Diseases and Rheumatoid Arthritis
- Subjects with Clinical Attachment Loss>=3mm, Probing Depth >= 3mm and bleeding on probing (as defined by World Workshop 2017- criteria for periodontitis) in clinical examination will be included in the study population.
Key exclusion criteria (2 listed)
- Subjects with more than 32 teeth
- Subjects with no clinical registrations
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 |
|---|---|---|
| Periodontal treatmentIt includes surgical and non-surgical procedures depending on patient as well as tooth level. | Procedure or surgery | – |
Primary outcome
Treatment frequency and type of treatment services
Time frame: 25 years
Number of treatment and odontological treatment services due to periodontitis
Treatment frequency and type of treatment services among patients with medical diseases
Time frame: 25 years
Number of treatment and odontological treatment services among patients with medical diseases due to periodontitis
Effect on medical diseases
Time frame: 25 years
Risk of medical diseases based on periodontal disease extent and received periodontal treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 23627881Kongstad J, Ekstrand K, Qvist V, Christensen LB, Cortsen B, Gronbaek M, Holm-Pedersen P, Holmstrup P, Bardow A, Twetman S, Fiehn NE. Findings from the oral health study of the Danish Health Examination Survey 2007-2008. Acta Odontol Scand. 2013 Nov;71(6):1560-9. doi: 10.3109/00016357.2013.776701. Epub 2013 Apr 29.
- Background: PubMed 28128681Kongstad J, Enevold C, Christensen LB, Fiehn NE, Holmstrup P. Impact of Periodontitis Case Criteria: A Cross-Sectional Study of Lifestyle. J Periodontol. 2017 Jun;88(6):602-609. doi: 10.1902/jop.2017.160426. Epub 2017 Jan 27.
- Background: PubMed 27372888Hansen GM, Egeberg A, Holmstrup P, Hansen PR. Relation of Periodontitis to Risk of Cardiovascular and All-Cause Mortality (from a Danish Nationwide Cohort Study). Am J Cardiol. 2016 Aug 15;118(4):489-93. doi: 10.1016/j.amjcard.2016.05.036. Epub 2016 May 30.
- Background: PubMed 28748036Holmstrup P, Damgaard C, Olsen I, Klinge B, Flyvbjerg A, Nielsen CH, Hansen PR. Comorbidity of periodontal disease: two sides of the same coin? An introduction for the clinician. J Oral Microbiol. 2017 Jun 14;9(1):1332710. doi: 10.1080/20002297.2017.1332710. eCollection 2017.
- Background: PubMed 35612803Hansen PR, Holmstrup P. Cardiovascular Diseases and Periodontitis. Adv Exp Med Biol. 2022;1373:261-280. doi: 10.1007/978-3-030-96881-6_14.
- Background: PubMed 22228465Joseph R, Rajappan S, Nath SG, Paul BJ. Association between chronic periodontitis and rheumatoid arthritis: a hospital-based case-control study. Rheumatol Int. 2013 Jan;33(1):103-9. doi: 10.1007/s00296-011-2284-1. Epub 2012 Jan 7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Anne Havemose Poulsen study director
Head of Department
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Diabetes Mellitus, Type 2, run by University of Copenhagen.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Damgaard (+4525323832, chrd@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment frequency and type of treatment services (time frame: 25 years). The study lists 3 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 NCT05574231, which also lists 6 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 Oct 2022.