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

28. januar 2020 opdateret af: Göteborg University

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

800

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sverige
      • Gothenburg, Sverige, SE 405 30
        • Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
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.
Aktiv komparator: 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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
"Periodontal pocket closure"
Tidsramme: Up to 18 months
Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding
Up to 18 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Probing pocket depth
Tidsramme: Up to 18 months
Reduction in mean Probing pocket depth
Up to 18 months
Bleeding on pocket probing (BoP)
Tidsramme: Up to 18 months
Reduction in frequency of bleeding on pocket probing (BoP)
Up to 18 months
Patient-reported outcome measures (PROM)
Tidsramme: Up to 18 months
Questionnaire
Up to 18 months
Patient-reported experience measures (PREM)
Tidsramme: Up to 18 months
Questionnaire
Up to 18 months
Investment for treatment
Tidsramme: Up to 18 months
Individual investment for treatment - Direct and subsidiary costs
Up to 18 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plaque score
Tidsramme: Up to 18 months
Percentage of tooth surfaces with bacterial deposits
Up to 18 months
Treatment time
Tidsramme: Up to 18 months
Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively
Up to 18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Göteborg University

Samarbejdspartnere

Vastra Gotaland Region

Efterforskere

  • Ledende efterforsker: Jan L Wennstrom, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
  • Studieleder: Maria Welander, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
  • Studieleder: Kajsa H Abrahamsson, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

31. december 2019

Studieafslutning (Forventet)

31. december 2022

Datoer for studieregistrering

Først indsendt

10. april 2014

Først indsendt, der opfyldte QC-kriterier

18. juni 2014

Først opslået (Skøn)

20. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VGR 2013-2

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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