- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04023500
Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview
Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Bleeding on probing (BoP)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mirkka Järvinen, MNS, University of Turku
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Anticipato)
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
Altri numeri di identificazione dello studio
- University of Turku
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .