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

Chronic Periodontitis Clinical Trial

Official title:

Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02168621
• Other study ID #: VGR 2013-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plaque score	Percentage of tooth surfaces with bacterial deposits	Up to 18 months
Other	Treatment time	Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively	Up to 18 months
Primary	"Periodontal pocket closure"	Frequency of sites with probing pocket depth (PPD) =4 mm and no bleeding	Up to 18 months
Secondary	Probing pocket depth	Reduction in mean Probing pocket depth	Up to 18 months
Secondary	Bleeding on pocket probing (BoP)	Reduction in frequency of bleeding on pocket probing (BoP)	Up to 18 months
Secondary	Patient-reported outcome measures (PROM)	Questionnaire	Up to 18 months
Secondary	Patient-reported experience measures (PREM)	Questionnaire	Up to 18 months
Secondary	Investment for treatment	Individual investment for treatment - Direct and subsidiary costs	Up to 18 months