Intervention Study of Two Protocols for Non-surgical Treatment of Chronic Periodontitis

Not Applicable

• Conditions: Chronic Periodontitis
• Interventions: Procedure: Section-wise scaling and root planing; Procedure: Full-mouth ultrasonic debridement

• Registration Number: NCT02168621
• Lead Sponsor: Göteborg University

Brief 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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Primary Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Section-wise scaling and root planing	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.
Full-mouth ultrasonic debridement	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.

Primary Outcome Measures

Name	Time	Method
"Periodontal pocket closure"	Up to 18 months	Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding

Secondary Outcome Measures

Name	Time	Method
Bleeding on pocket probing (BoP)	Up to 18 months	Reduction in frequency of bleeding on pocket probing (BoP)
Patient-reported experience measures (PREM)	Up to 18 months	Questionnaire
Investment for treatment	Up to 18 months	Individual investment for treatment - Direct and subsidiary costs
Probing pocket depth	Up to 18 months	Reduction in mean Probing pocket depth
Patient-reported outcome measures (PROM)	Up to 18 months	Questionnaire

Trial Locations

Locations (1)

Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg; 🇸🇪 Gothenburg, Sweden