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

October 5, 2022 updated by: Christian Damgaard, University of Copenhagen

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christian Damgaard
  • Phone Number: +4525323832
  • Email: chrd@sund.ku.dk

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment frequency and type of treatment services
Time Frame: 25 years
Number of treatment and odontological treatment services due to periodontitis
25 years
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
25 years
Effect on medical diseases
Time Frame: 25 years
Risk of medical diseases based on periodontal disease extent and received periodontal treatment
25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Plandent A/S

Investigators

  • Study Director: Anne Havemose Poulsen, head of department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 522-0018/22-3800 (Other Grant/Funding Number: Plandent A/S)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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