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

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ClinicalTrials.gov Identifier: NCT02168621
Recruitment Status : Active, not recruiting
First Posted : June 20, 2014
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Full-mouth ultrasonic debridement Procedure: Section-wise scaling and root planing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.
Study Start Date : February 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. "Periodontal pocket closure" [ Time Frame: Up to 18 months ]
    Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding


Secondary Outcome Measures :
  1. Probing pocket depth [ Time Frame: Up to 18 months ]
    Reduction in mean Probing pocket depth

  2. Bleeding on pocket probing (BoP) [ Time Frame: Up to 18 months ]
    Reduction in frequency of bleeding on pocket probing (BoP)

  3. Patient-reported outcome measures (PROM) [ Time Frame: Up to 18 months ]
    Questionnaire

  4. Patient-reported experience measures (PREM) [ Time Frame: Up to 18 months ]
    Questionnaire

  5. Investment for treatment [ Time Frame: Up to 18 months ]
    Individual investment for treatment - Direct and subsidiary costs


Other Outcome Measures:
  1. Plaque score [ Time Frame: Up to 18 months ]
    Percentage of tooth surfaces with bacterial deposits

  2. Treatment time [ Time Frame: Up to 18 months ]
    Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168621


Locations
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Sweden
Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg
Gothenburg, Sweden, SE 405 30
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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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

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02168621     History of Changes
Other Study ID Numbers: VGR 2013-2
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

Keywords provided by Göteborg University:
Chronic periodontitis
Non-surgical therapy
Ultrasonic debridement
Scaling and root planing

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases