- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688278
HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis (DENT-PC)
Early Detection of Elevated Blood Sugar in Patients With Advanced Periodontitis: a Feasibility Study
This study will evaluate whether HbA1c screening can be performed in dental care to detect elevated blood glucose in patients with advanced periodontitis and support referral to primary care.
Periodontitis is a common chronic inflammatory disease affecting the supporting tissues of the teeth. Advanced periodontitis is associated with prediabetes, type 2 diabetes and cardiovascular disease. The relationship between periodontitis and diabetes is bidirectional: diabetes increases the risk and severity of periodontitis, while periodontal inflammation may contribute to impaired glucose regulation. Patients with advanced periodontitis may therefore represent a group at increased risk of undetected elevated blood glucose. Many of these patients visit dental care regularly but may not otherwise be reached by structured medical prevention.
This is a cross-sectional observational feasibility study conducted in public dental clinics in Skåne, Sweden, in collaboration with primary care. Adult patients aged 18 years or older with advanced periodontitis, defined as periodontitis stage 3-4 or grade B/C, will be invited to participate during a routine dental visit. Patients with previously diagnosed diabetes will not be included.
After informed consent, participants will complete or update a health declaration and undergo capillary HbA1c testing at the dental clinic using a validated point-of-care instrument. Participants will receive their test result. Those with HbA1c ≥42 mmol/mol will receive standardized information and be referred to their listed primary care centre for further diagnostic assessment and preventive follow-up according to routine clinical practice.
The study will assess how feasible this pathway is in routine dental care. Outcomes include participation rate, successful HbA1c testing, time required for study procedures, prevalence of elevated HbA1c, proportion referred to primary care, completed primary care follow-up within six months, dropout and costs. Follow-up data will be collected from medical records and regional registers.
The study may provide a practical model for collaboration between dental care and primary care, with the long-term aim of improving early detection of prediabetes and diabetes and strengthening preventive care for patients with advanced periodontitis.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susanna Calling
- Phone Number: +46724640728
- Email: susanna.calling@med.lu.se
Study Contact Backup
- Name: Peter Nymberg
- Email: peter.nymberg@med.lu.se
Study Locations
-
-
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Skåne, Sweden
- Recruiting
- Folktandvården Skåne AB
-
Contact:
- Nils Oscarson
- Phone Number: +46 70 277 33 57
- Email: nils.oscarson@folktandvardenskane.se
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Principal Investigator:
- Nils Oscarson
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older.
- Advanced periodontitis, defined as stage 3-4 periodontitis or grade B/C periodontitis according to clinical and radiographic assessment during routine dental care.
- Ability to understand study information and provide informed consent.
Exclusion Criteria:
- Previously diagnosed diabetes mellitus.
- Inability to provide informed consent, for example due to severe mental disorder or markedly impaired health status as judged by the clinical staff.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HbA1c Screening in Dental Care
Adult patients with advanced periodontitis undergo point-of-care HbA1c screening during a routine dental care visit.
Patients with HbA1c ≥42 mmol/mol receive standardized information and are referred to primary care for further assessment and preventive follow-up.
|
All participants undergo capillary HbA1c testing at the dental clinic using a validated point-of-care instrument.
Test results are provided to the participant during the visit.
Participants with HbA1c ≥42 mmol/mol receive standardized information about the elevated test result and are referred to their listed primary care centre for further diagnostic assessment and preventive follow-up according to routine clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation rate
Time Frame: 6 months
|
Number of participants included out of those who meet the inclusion criteria.
Reasons for non-participation will be recorded in free text.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants with HbA1c 42 mmol/mol or higher.
Time Frame: 6 months
|
Proportion of participants with HbA1c 42 mmol/mol or higher
|
6 months
|
|
Proportion of patients undergoing blood pressure examination at follow-up in primary care
Time Frame: 6 months
|
Through review of medical records at the patient's primary health care center, assessment of proportion of patients undergoing blood pressure examination.
|
6 months
|
|
Proportion of patients undergoing blood lipid laboratory samples
Time Frame: 6 months
|
Through review of medical records in primary care, assessment of proportion of patients undergoing blood lipid laboratory sample.
|
6 months
|
|
Diagnosis at follow-up
Time Frame: 6 months
|
Diagnosis registered at the follow-up in primary care
|
6 months
|
|
Proportion of patients receiving lifestyle advice at follow-up
Time Frame: 6 months
|
Through review of medical records at follow-up in primary care, assessment of proportion of patients receiving advice on lifestyle habits.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Periodontitis
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Prediabetic State
- Chronic Periodontitis
Other Study ID Numbers
- 2025-01744-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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