- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Susanna Calling
- Numéro de téléphone: +46724640728
- E-mail: susanna.calling@med.lu.se
Sauvegarde des contacts de l'étude
- Nom: Peter Nymberg
- E-mail: peter.nymberg@med.lu.se
Lieux d'étude
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Skåne, Suède
- Recrutement
- Folktandvården Skåne AB
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Contact:
- Nils Oscarson
- Numéro de téléphone: +46 70 277 33 57
- E-mail: nils.oscarson@folktandvardenskane.se
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Chercheur principal:
- Nils Oscarson
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Participation rate
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of participants with HbA1c 42 mmol/mol or higher.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies parodontales
- Maladies de la bouche
- Maladies stomatognathiques
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Diabète sucré
- Parodontite
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Diabète sucré, Type 2
- État prédiabétique
- Parodontite chronique
Autres numéros d'identification d'étude
- 2025-01744-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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