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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168621
Recruitment Status : Active, not recruiting
First Posted : June 20, 2014
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Tracking Information
First Submitted Date  ICMJE April 10, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date January 29, 2020
Study Start Date  ICMJE February 2014
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
"Periodontal pocket closure" [ Time Frame: Up to 18 months ]
Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Frequency of "Pocket closure" i.e. probing pocket depth (PPD) ≤4 mm and no bleeding [ Time Frame: Up to 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Probing pocket depth [ Time Frame: Up to 18 months ]
    Reduction in mean Probing pocket depth
  • Bleeding on pocket probing (BoP) [ Time Frame: Up to 18 months ]
    Reduction in frequency of bleeding on pocket probing (BoP)
  • Patient-reported outcome measures (PROM) [ Time Frame: Up to 18 months ]
    Questionnaire
  • Patient-reported experience measures (PREM) [ Time Frame: Up to 18 months ]
    Questionnaire
  • Investment for treatment [ Time Frame: Up to 18 months ]
    Individual investment for treatment - Direct and subsidiary costs
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • Reduction in mean probing pocket depth [ Time Frame: Up to 18 months ]
  • Reduction in frequency of bleeding on pocket probing (BoP) [ Time Frame: Up to 18 months ]
  • Patient-reported outcome measures (PROM) [ Time Frame: Up to 18 months ]
    Questionnaire
  • Patient-reported experience measures (PREM) [ Time Frame: Up to 18 months ]
    Questionnaire
  • Individual investment for treatment - Direct and subsidiary costs [ Time Frame: Up to 18 months ]
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2019)
  • Plaque score [ Time Frame: Up to 18 months ]
    Percentage of tooth surfaces with bacterial deposits
  • Treatment time [ Time Frame: Up to 18 months ]
    Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively
Original Other Pre-specified Outcome Measures
 (submitted: June 18, 2014)
  • Plaque score [ Time Frame: Up to 18 months ]
  • Treatment time for mechanical instrumentation and oral hygiene instructions [ Time Frame: Up to 18 months ]
 
Descriptive Information
Brief Title  ICMJE Intervention Study of Two Protocols for Non-surgical Treatment of Chronic Periodontitis
Official Title  ICMJE Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Periodontitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Procedure: Full-mouth ultrasonic debridement
  • Active Comparator: 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.
    Intervention: Procedure: Section-wise scaling and root planing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2018)
800
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
1100
Estimated Study Completion Date  ICMJE December 31, 2022
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168621
Other Study ID Numbers  ICMJE VGR 2013-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Vastra Gotaland Region
Investigators  ICMJE
Principal Investigator: Jan L Wennstrom Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
Study Director: Maria Welander Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
Study Director: Kajsa H Abrahamsson Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
PRS Account Göteborg University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP