Clinical trial NCT02168621: Intervention Study of Two Protocols for Non-surgical Treatment of Chronic Periodontitis
Official title: Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis
Non-surgical therapy
Ultrasonic debridement
Scaling and root planing
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2014-06-20
Enrollment: 800
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: "Periodontal pocket closure"
timeFrame: Up to 18 months
Secondary outcomes:
measure: Probing pocket depth
timeFrame: Up to 18 months
measure: Bleeding on pocket probing (BoP)
timeFrame: Up to 18 months
measure: Patient-reported outcome measures (PROM)
timeFrame: Up to 18 months
measure: Patient-reported experience measures (PREM)
timeFrame: Up to 18 months
measure: Investment for treatment
timeFrame: Up to 18 months
Other outcomes:
measure: Plaque score
timeFrame: Up to 18 months
measure: Treatment time
timeFrame: Up to 18 months
Locations:
city: Gothenburg
country: Sweden
facility: Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg
Study officials:
affiliation: Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
name: Jan L Wennstrom
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
name: Maria Welander
role: STUDY_DIRECTOR
affiliation: Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
name: Kajsa H Abrahamsson
role: STUDY_DIRECTOR
References:
citation: Tomasi C, Liss A, Welander M, Alian AY, Abrahamsson KH, Wennstrom JL. A randomized multi-centre study on the effectiveness of non-surgical periodontal therapy in general practice. J Clin Periodontol. 2022 Nov;49(11):1092-1105. doi: 10.1111/jcpe.13703. Epub 2022 Jul 27.
citation: Liss A, Wennstrom JL, Welander M, Tomasi C, Petzold M, Abrahamsson KH. Patient-reported experiences and outcomes following two different approaches for non-surgical periodontal treatment: a randomized field study. BMC Oral Health. 2021 Dec 15;21(1):645. doi: 10.1186/s12903-021-02001-4.