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

NCT02168621 | Unknown

• 1 other identifier: VGR 2013-2
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis; Non-surgical therapy; Ultrasonic debridement; Scaling and root planing

Outcome Measures

Primary Outcomes (1)

• "Periodontal pocket closure"

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

  Up to 18 months

Secondary Outcomes (5)

• Probing pocket depth

  Up to 18 months

• Bleeding on pocket probing (BoP)

  Up to 18 months

• Patient-reported outcome measures (PROM)

  Up to 18 months

• Patient-reported experience measures (PREM)

  Up to 18 months

• Investment for treatment

  Up to 18 months

Other Outcomes (2)

• Plaque score

  Up to 18 months

• Treatment time

  Up to 18 months

Study Arms (2)

Full-mouth ultrasonic debridement

ACTIVE COMPARATOR

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

Section-wise scaling and root planing

ACTIVE COMPARATOR

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

Interventions

Full-mouth ultrasonic debridement PROCEDURE

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.

Full-mouth ultrasonic debridement

Section-wise scaling and root planing PROCEDURE

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.

Section-wise scaling and root planing

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic periodontitis
• at least 6 teeth with approximal probing pocket depth ≥5 mm and bleeding on probing

You may not qualify if:

• subgingival instrumentation within 6 months prior to screening examination
• compromised medical conditions requiring prophylactic antibiotic coverage

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

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

Gothenburg, SE 405 30, Sweden

Location

Related Publications (2)

• 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.

  PMID: 35833528 DERIVED

• 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.

  PMID: 34911530 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Jan L Wennstrom

  Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: June 20, 2014
• Study Start: February 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2022
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

SE (1)