Clinical trial NCT03509233: Anti-infectious Therapy of Periodontitis - Comparison of Different Clinical Strategies
Official title: Anti-infectious Therapy of Chronic Periodontitis Using One Stage Full Mouth Disinfection With Subgingival Airpolishing - a Comparison of Different Clinical Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: periodontitis
full mouth scaling
air abrasion
scaling
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter randomized controlled intervention trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of clinical attachment level
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Change of pocket probing depth
timeFrame: Baseline, 3 months, 6 months
measure: Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola
timeFrame: Baseline, 3 months, 6 months
measure: Change of bleeding on probing
timeFrame: Baseline, 3 months, 6 months
measure: Change of gingival index
timeFrame: Baseline, 3 months, 6 months
measure: Change of plaque index
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde
city: Berlin
country: Germany
facility: Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin
city: Halle (Saale)
country: Germany
facility: Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie
city: Timişoara
country: Romania
facility: Department of Dental Medicine 1 (Periodontology)
Study officials:
affiliation: Universitätsklinikum RWTH Aachen
name: Jamal M. Stein, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Abdelbary MMH, Schittenhelm F, Yekta-Michael SS, Reichert S, Schulz S, Kasaj A, Braun A, Conrads G, Stein JM. Impact of Three Nonsurgical, Full-Mouth Periodontal Treatments on Total Bacterial Load and Selected Pathobionts. Antibiotics (Basel). 2022 May 19;11(5):686. doi: 10.3390/antibiotics11050686.
citation: Schulz S, Stein JM, Schumacher A, Kupietz D, Yekta-Michael SS, Schittenhelm F, Conrads G, Schaller HG, Reichert S. Nonsurgical Periodontal Treatment Options and Their Impact on Subgingival Microbiota. J Clin Med. 2022 Feb 23;11(5):1187. doi: 10.3390/jcm11051187.
citation: Stein JM, Yekta-Michael SS, Schittenhelm F, Reichert S, Kupietz D, Dommisch H, Kasaj A, Wied S, Vela OC, Stratul SI. Comparison of three full-mouth concepts for the non-surgical treatment of stage III and IV periodontitis: A randomized controlled trial. J Clin Periodontol. 2021 Dec;48(12):1516-1527. doi: 10.1111/jcpe.13548. Epub 2021 Oct 4.