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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: Full-mouth ultrasonic debridement; Procedure: Section-wise scaling and root planing

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: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Periodontal pocket closure"	Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding	Up to 18 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque score	Percentage of tooth surfaces with bacterial deposits	Up to 18 months
Treatment time	Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively	Up to 18 months

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Chronic periodontitis; Scaling and root planing; Non-surgical therapy; Ultrasonic debridement
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: VGR 2013-2