HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Point-of-care HbA1c screening

    Diagnostic test

    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.

  • Conditional standardized primary care referral

    Other intervention

    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.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: HbA1c Screening in Dental CareExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Participation rate

Number of participants included out of those who meet the inclusion criteria. Reasons for non-participation will be recorded in free text.

Time frame
6 months

Secondary outcomes

1

Proportion of participants with HbA1c 42 mmol/mol or higher.

Proportion of participants with HbA1c 42 mmol/mol or higher

Time frame
6 months
2

Proportion of patients undergoing blood pressure examination at follow-up in primary care

Through review of medical records at the patient's primary health care center, assessment of proportion of patients undergoing blood pressure examination.

Time frame
6 months
3

Proportion of patients undergoing blood lipid laboratory samples

Through review of medical records in primary care, assessment of proportion of patients undergoing blood lipid laboratory sample.

Time frame
6 months
4

Diagnosis at follow-up

Diagnosis registered at the follow-up in primary care

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Folktandvården Skåne AB

Collaborator