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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Full-mouth ultrasonic debridement
* Procedure: Section-wise scaling and root planing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full-mouth ultrasonic debridement<br>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. | Procedure: Full-mouth ultrasonic debridement<br>* 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.<br>|
| Active Comparator: Section-wise scaling and root planing<br>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. | Procedure: Section-wise scaling and root planing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal pocket closure | Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding | Up to 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scaling and root planing, Chronic periodontitis, Non-surgical therapy, Ultrasonic debridement