NCT02168621

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2019-12-31
• Completion: 2022-12-31
• First posted: 2014-06-20
• Last updated: 2020-01-29

Locations

1 site across 1 country: Sweden