Intervention Study of Two Protocols for Non-surgical Treatment of Chronic Periodontitis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1100
Summary
- Conditions
- Chronic Periodontitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02168621
- 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
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