- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Susanna Calling
- Numero di telefono: +46724640728
- Email: susanna.calling@med.lu.se
Backup dei contatti dello studio
- Nome: Peter Nymberg
- Email: peter.nymberg@med.lu.se
Luoghi di studio
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Skåne, Svezia
- Reclutamento
- Folktandvården Skåne AB
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Contatto:
- Nils Oscarson
- Numero di telefono: +46 70 277 33 57
- Email: nils.oscarson@folktandvardenskane.se
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Investigatore principale:
- Nils Oscarson
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Participation rate
Lasso di tempo: 6 months
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Number of participants included out of those who meet the inclusion criteria.
Reasons for non-participation will be recorded in free text.
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of participants with HbA1c 42 mmol/mol or higher.
Lasso di tempo: 6 months
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Proportion of participants with HbA1c 42 mmol/mol or higher
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6 months
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Proportion of patients undergoing blood pressure examination at follow-up in primary care
Lasso di tempo: 6 months
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Through review of medical records at the patient's primary health care center, assessment of proportion of patients undergoing blood pressure examination.
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6 months
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Proportion of patients undergoing blood lipid laboratory samples
Lasso di tempo: 6 months
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Through review of medical records in primary care, assessment of proportion of patients undergoing blood lipid laboratory sample.
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6 months
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Diagnosis at follow-up
Lasso di tempo: 6 months
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Diagnosis registered at the follow-up in primary care
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6 months
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Proportion of patients receiving lifestyle advice at follow-up
Lasso di tempo: 6 months
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Through review of medical records at follow-up in primary care, assessment of proportion of patients receiving advice on lifestyle habits.
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6 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Malattie parodontali
- Malattie della bocca
- Malattie stomatognatiche
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Malattie metaboliche
- Disturbi del metabolismo del glucosio
- Diabete mellito
- Parodontite
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Diabete mellito, tipo 2
- Stato prediabetico
- Parodontite cronica
Altri numeri di identificazione dello studio
- 2025-01744-01
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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