Anti-infectious Therapy of Chronic Periodontitis Using One Stage Full Mouth Disinfection With Subgingival Airpolishing - a Comparison of Different Clinical Strategies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periodontitis
- Sponsor
- RWTH Aachen University
- Enrollment
- 228
- Locations
- 5
- Primary Endpoint
- Change of clinical attachment level
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
It is the aim of the study to evaluate the efficiency of "One stage full mouth disinfection" according to the original protocol (Quirynen et al. 1995) in comparison to other approaches considering different scaling strategies and different disinfection concepts. Therefore, a multicenter randomized control treatment will be performed. In total, 204 patients with chronic periodontitis shall be allocated to the following treatment concepts. Group A: quadrant scaling with weekly intervals (Q-SRP; N = 51); Group B: full mouth scaling (FMS; N = 51); Group C: full mouth disinfection (FMD; N = 51); Group D: full mouth disinfection with subgingival glycine air polishing using erythritol powder (FMDP; N = 51). Evaluation of periodontopathic parameters and periodontal pathogens at baseline, 3 months and 6 months shall give evidence about the benefits of concept and the single components of FMD.
Investigators
Sareh Michael
Dr. med.
RWTH Aachen University
Eligibility Criteria
Inclusion Criteria
- •patients with generalized moderate to severe chronic periodontitis
- •presence of at least 18 teeth
- •with at least 2 multi-rooted and / or 2 single-rooted teeth in the first quadrant with at least 6 sites with periodontal probing depth of ≥ 6 mm
- •radiographic bone loss of at least 25% of the root length
Exclusion Criteria
- •subgingival scaling and root planing within the last 12 months
- •antimicrobial rinsing or intake of systemic antibiotics within the last 4 months
- •systemic diseases with known interactions to periodontal disease or known need for antibiotic prophylaxis
- •known intolerance / allergies to chlorhexidine
- •pregnancy
Outcomes
Primary Outcomes
Change of clinical attachment level
Time Frame: Baseline, 3 months, 6 months
Measuring the change of the distance between the cemento-enamel junction and the bottom of the periodontal pocket 3 and 6 months after therapy compared to baseline
Secondary Outcomes
- Change of bleeding on probing(Baseline, 3 months, 6 months)
- Change of gingival index(Baseline, 3 months, 6 months)
- Change of pocket probing depth(Baseline, 3 months, 6 months)
- Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola(Baseline, 3 months, 6 months)
- Change of plaque index(Baseline, 3 months, 6 months)