Chronic Periodontitis Clinical Trial
Official title:
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.
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.
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