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

NCT02168621 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2020-01-29

No results posted yet for this study

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.

Conditions

  • Chronic Periodontitis

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Göteborg University

    lead OTHER

Principal Investigators

  • Jan L Wennstrom · Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

  • Maria Welander · Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

  • Kajsa H Abrahamsson · Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-12-31
Completion
2022-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168621 on ClinicalTrials.gov