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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Gothenburg, Szwecja, SE 405 30
- Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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"Periodontal pocket closure"
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Probing pocket depth
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Up to 18 months
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Questionnaire
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Up to 18 months
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Investment for treatment
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Plaque score
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Jan L Wennstrom, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
- Dyrektor Studium: Maria Welander, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
- Dyrektor Studium: Kajsa H Abrahamsson, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- VGR 2013-2
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