Clinical trial NCT05574231: A Danish Nationwide Longitudinal Study on Prevalence of Periodontitis and Its Co-morbidities
Official title: A Danish Nationwide Longitudinal Registered Based Study on Prevalence, Treatment Patterns and Disease Trajectories of Periodontitis and Co-morbidities 'PlanPerioMed'
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Periodontitis
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Rheumatoid Arthritis
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
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Plandent A/S
First posted: 2022-10-10
Enrollment: 4000000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include people who are clinically diagnosed with periodontal diseases and private practice dental care attenders in Denmark.

Brief 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:

* 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subjects with more than 32 teeth
* Subjects with no clinical registrations

Primary outcomes:
measure: Treatment frequency and type of treatment services
timeFrame: 25 years
measure: Treatment frequency and type of treatment services among patients with medical diseases
timeFrame: 25 years
measure: Effect on medical diseases
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Head of Department
name: Anne Havemose Poulsen
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Kongstad 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.
citation: Hansen 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.
citation: Holmstrup 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.
citation: Hansen PR, Holmstrup P. Cardiovascular Diseases and Periodontitis. Adv Exp Med Biol. 2022;1373:261-280. doi: 10.1007/978-3-030-96881-6_14.
citation: Joseph 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.