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

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Full-mouth ultrasonic debridement
Section-wise scaling and root planing
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic periodontitis, Non-surgical therapy, Ultrasonic debridement, Scaling and root planing

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Full-mouth ultrasonic debridement

Section-wise scaling and root planing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

"Periodontal pocket closure"
Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2014
Last Updated
January 28, 2020
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT02168621
Brief Title
Intervention Study of Two Protocols for Non-surgical Treatment of Chronic Periodontitis
Official Title
Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic periodontitis, Non-surgical therapy, Ultrasonic debridement, Scaling and root planing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full-mouth ultrasonic debridement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Section-wise scaling and root planing
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Full-mouth ultrasonic debridement
Intervention Description
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
Intervention Name(s)
Section-wise scaling and root planing
Intervention Description
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 Measure Information:
Title
"Periodontal pocket closure"
Description
Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
Reduction in mean Probing pocket depth
Time Frame
Up to 18 months
Title
Bleeding on pocket probing (BoP)
Description
Reduction in frequency of bleeding on pocket probing (BoP)
Time Frame
Up to 18 months
Title
Patient-reported outcome measures (PROM)
Description
Questionnaire
Time Frame
Up to 18 months
Title
Patient-reported experience measures (PREM)
Description
Questionnaire
Time Frame
Up to 18 months
Title
Investment for treatment
Description
Individual investment for treatment - Direct and subsidiary costs
Time Frame
Up to 18 months
Other Pre-specified Outcome Measures:
Title
Plaque score
Description
Percentage of tooth surfaces with bacterial deposits
Time Frame
Up to 18 months
Title
Treatment time
Description
Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively
Time Frame
Up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan L Wennstrom
Organizational Affiliation
Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Welander
Organizational Affiliation
Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kajsa H Abrahamsson
Organizational Affiliation
Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg
City
Gothenburg
ZIP/Postal Code
SE 405 30
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35833528
Citation
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.
Results Reference
derived
PubMed Identifier
34911530
Citation
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.
Results Reference
derived

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

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