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HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis (DENT-PC)

30. juni 2026 oppdatert av: Region Skane

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

600

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participation rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants with HbA1c 42 mmol/mol or higher.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
Diagnosis registered at the follow-up in primary care
6 months
Proportion of patients receiving lifestyle advice at follow-up
Tidsramme: 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

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Sponsor

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

30. juli 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

30. juni 2026

Først lagt ut (Faktiske)

7. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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