NCT05574231

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

3.1 years

First QC Date

September 1, 2022

Last Update Submit

October 5, 2022

Conditions

Keywords

Periodontal Diseases, Periodontal Index, Periodontal Bone Loss, Periodontal Attachment Loss, Probing Depth, Bleeding on Probing, Clinical Attachment LossDiabetes Mellitus 2, DM type 2, Non-insulin dependent diabetes mellitus, Uncontrolled diabetes mellitus type 2, Increased blood glucose levelCVD, Cardiovascular risk, Heart disease, Heart disease risk factorsSmoking status, Socio-economic status, Register based, Longitudinal study, Danish nationwide study, systemic diseases

Outcome Measures

Primary Outcomes (3)

  • Treatment frequency and type of treatment services

    Number of treatment and odontological treatment services due to periodontitis

    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

    25 years

  • Effect on medical diseases

    Risk of medical diseases based on periodontal disease extent and received periodontal treatment

    25 years

Interventions

It includes surgical and non-surgical procedures depending on patient as well as tooth level.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will include people who are clinically diagnosed with periodontal diseases and private practice dental care attenders in Denmark.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 23627881BACKGROUND
  • 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.

    PMID: 28128681BACKGROUND
  • 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.

    PMID: 27372888BACKGROUND
  • 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.

    PMID: 28748036BACKGROUND
  • 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.

    PMID: 35612803BACKGROUND
  • 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.

    PMID: 22228465BACKGROUND

Related Links

MeSH Terms

Conditions

PeriodontitisDiabetes Mellitus, Type 2Cardiovascular DiseasesArthritis, RheumatoidPeriodontal DiseasesAlveolar Bone LossPeriodontal Attachment LossHeart Diseases

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone ResorptionBone DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • Anne Havemose Poulsen

    Head of Department

    STUDY DIRECTOR

Central Study Contacts

Christian Damgaard

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
25 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Head of Section

Study Record Dates

First Submitted

September 1, 2022

First Posted

October 10, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share