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

NCT ID: NCT02168621

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2022-12-31

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Full-mouth ultrasonic debridement

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Section-wise scaling and root planing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan L Wennstrom

Role: PRINCIPAL_INVESTIGATOR

Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

Maria Welander

Role: STUDY_DIRECTOR

Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

Kajsa H Abrahamsson

Role: STUDY_DIRECTOR

Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

Locations

Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg

Gothenburg, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 35833528 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34911530 (View on PubMed)

Other Identifiers

VGR 2013-2

Identifier Type: -

Identifier Source: org_study_id