Intervention Study of Two Protocols for Non-surgical Treatment of Chronic Periodontitis
Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.
Treatment directed towards the control of periodontal infections is to about 90% non-surgical procedures. There is evidence from a large number of randomized controlled studies that the efficacy in terms of clinical outcomes of a full-mouth ultrasonic debridement approach (FMUD) is comparable to that of traditional section-wise scaling and root planing (SRP). A hypothesis for the current effectiveness study is that comparable clinical effects will be obtained with the FMUD approach as with conventional section-wise SRP, but with significantly more favourable patient-centred and health-economic outcomes.
This randomized study involves about 100 professionals (dental hygienists) and more than 850 patients at 40 dental clinics in the Vastra Gotaland Region, Sweden. The project not only evaluate treatment effects in terms of pertinent clinical outcomes, it also has a strong focus on patient-centered measures - patient-reported experience measures (PREM) and patient-reported outcome measures (PROM) - as well as health-economics.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
All patients with chronic periodontitis (age 30 years and older) attending the selected Public Dental clinics in VG are eligible. The patients should have at least 8 teeth with pathological pockets (probing pocket depth ≥5 mm and bleeding on probing). Only patients providing signed informed consent are included.
Reported data in the study by Wennström et al. (J Clin Periodontol 2005) were used for power calculation. Thus, a total sample of 834 patients will provide a power of 95% at a significance level of p<0.05 to detect a difference of 5% in proportion of sites with "pocket closure" i.e. PPD ≤4 mm and BoP negative (primary efficacy variable) between treatment groups. For a power of 80% a total sample of 506 patients is required.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Gothenburg, Svezia, SE 405 30
- Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- chronic periodontitis
- at least 6 teeth with approximal probing pocket depth ≥5 mm and bleeding on probing
Exclusion Criteria:
- subgingival instrumentation within 6 months prior to screening examination
- compromised medical conditions requiring prophylactic antibiotic coverage
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Full-mouth ultrasonic debridement
Motivation and instruction in proper oral hygiene.
Before initiation of the subgingival debridement the patient must show sufficient self-performed infection control (full-mouth plaque score <30%).
One session of full-mouth ultrasonic pocket/root debridement using a piezoceramic ultrasonic instrument.
A follow-up visit after 2-4 weeks is scheduled for oral hygiene control and re-motivation/re-instruction if indicated.
At 3 and 6 months re-evaluation is performed and re-instrumentation of all sites showing a remaining probing pocket depth of ≥5 mm carried out.
Final evaluation at 18 months.
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Motivation and instruction in proper oral hygiene.
Before initiation of the subgingival debridement the patient must show sufficient self-performed infection control (full-mouth plaque score <30%).
One session of full-mouth ultrasonic pocket/root debridement using a piezoceramic ultrasonic instrument.
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Comparatore attivo: Section-wise scaling and root planing
Conventional treatment approach comprising motivation, oral hygiene instructions and section-wise scaling and root planing at required number of consecutive appointments with 1-2 week interval.
Follow-up 2-4 weeks after the last session of SRP for oral hygiene control and re-instruction if indicated.
At 3 and 6 months re-evaluation is performed and re-instrumentation of all sites showing a remaining pocket depth of ≥5 mm carried out.
Final evaluation at 18 months.
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Conventional treatment approach comprising motivation, oral hygiene instructions and section-wise scaling and root planing at required number of consecutive appointments with 1-2 week interval.
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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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"Periodontal pocket closure"
Lasso di tempo: Up to 18 months
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Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding
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Up to 18 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Probing pocket depth
Lasso di tempo: Up to 18 months
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Reduction in mean Probing pocket depth
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Up to 18 months
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Bleeding on pocket probing (BoP)
Lasso di tempo: Up to 18 months
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Reduction in frequency of bleeding on pocket probing (BoP)
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Up to 18 months
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Patient-reported outcome measures (PROM)
Lasso di tempo: Up to 18 months
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Questionnaire
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Up to 18 months
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Patient-reported experience measures (PREM)
Lasso di tempo: Up to 18 months
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Questionnaire
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Up to 18 months
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Investment for treatment
Lasso di tempo: Up to 18 months
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Individual investment for treatment - Direct and subsidiary costs
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Up to 18 months
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Plaque score
Lasso di tempo: Up to 18 months
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Percentage of tooth surfaces with bacterial deposits
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Up to 18 months
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Treatment time
Lasso di tempo: Up to 18 months
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Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively
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Up to 18 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jan L Wennstrom, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
- Direttore dello studio: Maria Welander, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
- Direttore dello studio: Kajsa H Abrahamsson, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
Pubblicazioni e link utili
Pubblicazioni generali
- Tomasi C, Liss A, Welander M, Alian AY, Abrahamsson KH, Wennstrom JL. A randomized multi-centre study on the effectiveness of non-surgical periodontal therapy in general practice. J Clin Periodontol. 2022 Nov;49(11):1092-1105. doi: 10.1111/jcpe.13703. Epub 2022 Jul 27.
- Liss A, Wennstrom JL, Welander M, Tomasi C, Petzold M, Abrahamsson KH. Patient-reported experiences and outcomes following two different approaches for non-surgical periodontal treatment: a randomized field study. BMC Oral Health. 2021 Dec 15;21(1):645. doi: 10.1186/s12903-021-02001-4.
Studiare le date dei record
Studia le date principali
Inizio studio
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 (Stima)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VGR 2013-2
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 .