- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04023500
Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview
Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study is designed as a randomized, double-blinded, controlled clinical trial of 6-month duration involving patients with diagnosed periodontitis. The subjects are randomized to intervention or control group using the randomizing list.
For both groups, necessary non-surgical periodontal treatments will be done. In the intervention group The MI-intervention is used as a part of normal dental hygienist appointment and if patient need more than one visit, MI was used in every visit.
In control group prevailing, more professional-centered education is used. Dental hygienist define patients educational needs and give direct instructions how to change behaviour and self-care.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults, over 18-year-old
- CPI (Community periodontal index) 3 in at least two sextants and
- Diagnosed parodontitis
- The previous treatment period should have been more than one year ago.
Exclusion Criteria:
- pregnancy (or the planning of pregnancy)
- immunosuppressive illness or a medication,
- hepatitis, HIV, MRSA (methicillin-resistant Staphylococcus aureus)
- a bleeding illness or a anticoagulant (excluding primalan 100-200 mg / a day)
- the labile diabetes
- cytotoxic treatment
- a need for the antibiotic prophylaxis.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Motivational interview
The MI-intervention is used as a part of normal dental hygienist appointment.
Dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change.
They are supposed to use open-ended questions, reflective listening and reinforcing with patients.
Dental hygienist support patients in decision making although patients were addressed as an active agent.
|
In intervention group dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients. In control croup dental hygienist defined patients educational needs and gave direct instructions how to change behaviour and self-care. |
|
Comparateur actif: Prevailing education
In control group prevailing, more professional-centered education is used.
Dental hygienist define patients educational needs and give direct instructions how to change behaviour and self-care.
|
In intervention group dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients. In control croup dental hygienist defined patients educational needs and gave direct instructions how to change behaviour and self-care. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bleeding on probing (BoP)
Délai: Up to 6 month
|
Change in BoP is measured three times during the study. In the baseline and in the tree- and six-months follow-up. Bop is recorded60 seconds after the pocket probing and assessed as present (1) or absent (0) on four surfaces. |
Up to 6 month
|
|
Pocket probing depth (PD)
Délai: Up to 6 month
|
Change in PD is measured three times during the study.
In the baseline and in the tree- and six-months follow-up.
PD is measured at mesial, distal, lingual and buccal surfaces.
|
Up to 6 month
|
|
Clinical Attachment Level (CAL)
Délai: Up to 6 month
|
Change in CAL is measured three times during the study.
In the baseline and in the tree- and six-months follow-up.
CAL is measured if cemento-enamel junction is uncovered or if there is 6 mm deep or deeper gingival pocket.
|
Up to 6 month
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mirkka Järvinen, MNS, University of Turku
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
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
Autres numéros d'identification d'étude
- University of Turku
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
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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