A Danish Nationwide Longitudinal Study on Prevalence of Periodontitis and Its Co-morbidities

Diabetes Mellitus, Type 2 Clinical Trial

— PlanPerioMed  

Official title:

A Danish Nationwide Longitudinal Registered Based Study on Prevalence, Treatment Patterns and Disease Trajectories of Periodontitis and Co-morbidities 'PlanPerioMed'

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05574231
• Other study ID #: 522-0018/22-3800
• Secondary ID: 522-0018/22-3800
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: University of Copenhagen
• Contact: Christian Damgaard
• Phone: +4525323832
• Email: chrd[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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:

• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis
• Rheumatoid Arthritis

Intervention

Procedure:
• Periodontal treatment
It includes surgical and non-surgical procedures depending on patient as well as tooth level.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Plandent A/S

References & Publications (6)

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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Kongstad J, Ekstrand K, Qvist V, Christensen LB, Cortsen B, Grønbaek 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment frequency and type of treatment services	Number of treatment and odontological treatment services due to periodontitis	25 years
Primary	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	25 years
Primary	Effect on medical diseases	Risk of medical diseases based on periodontal disease extent and received periodontal treatment	25 years

External Links

•   Related Info