- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Susanna Calling
- Número de teléfono: +46724640728
- Correo electrónico: susanna.calling@med.lu.se
Copia de seguridad de contactos de estudio
- Nombre: Peter Nymberg
- Correo electrónico: peter.nymberg@med.lu.se
Ubicaciones de estudio
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Skåne, Suecia
- Reclutamiento
- Folktandvården Skåne AB
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Contacto:
- Nils Oscarson
- Número de teléfono: +46 70 277 33 57
- Correo electrónico: nils.oscarson@folktandvardenskane.se
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Investigador principal:
- Nils Oscarson
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participation rate
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants with HbA1c 42 mmol/mol or higher.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Periodontitis
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 2
- Estado prediabético
- Periodontitis Crónica
Otros números de identificación del estudio
- 2025-01744-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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