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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02168621
Enrollment
800
Registered
2014-06-20
Start date
2014-02-28
Completion date
2022-12-31
Last updated
2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis, Non-surgical therapy, Ultrasonic debridement, Scaling and root planing

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.

Interventions

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.

PROCEDURESection-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.

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Periodontal pocket closureUp to 18 monthsFrequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding

Secondary

MeasureTime frameDescription
Probing pocket depthUp to 18 monthsReduction in mean Probing pocket depth
Bleeding on pocket probing (BoP)Up to 18 monthsReduction in frequency of bleeding on pocket probing (BoP)
Patient-reported outcome measures (PROM)Up to 18 monthsQuestionnaire
Patient-reported experience measures (PREM)Up to 18 monthsQuestionnaire
Investment for treatmentUp to 18 monthsIndividual investment for treatment - Direct and subsidiary costs

Other

MeasureTime frameDescription
Plaque scoreUp to 18 monthsPercentage of tooth surfaces with bacterial deposits
Treatment timeUp to 18 monthsTreatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026