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

NCT07688278 | Recruiting

• 1 other identifier: 2025-01744-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis, Adult; Prediabetes / Type 2 Diabetes

Outcome Measures

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.

  6 months

Secondary Outcomes (5)

• 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

  6 months

• Proportion of patients undergoing blood lipid laboratory samples

  6 months

• Diagnosis at follow-up

  6 months

• Proportion of patients receiving lifestyle advice at follow-up

  6 months

Study Arms (1)

HbA1c Screening in Dental Care

EXPERIMENTAL

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.

Diagnostic Test: Point-of-care HbA1c screening; Other: Conditional standardized primary care referral

Interventions

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.

HbA1c Screening in Dental Care

Conditional standardized primary care referral OTHER

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.

HbA1c Screening in Dental Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead
• Folktandvården Skåne AB: collaborator

Study Sites (1)

Folktandvården Skåne AB

Skåne, Sweden

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis; Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Susanna Calling

CONTACT

+46724640728; susanna.calling@med.lu.se

Peter Nymberg

CONTACT

peter.nymberg@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)