Anti-infectious Therapy of Periodontitis - Comparison of Different Clinical Strategies

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Other: Q-SRP; Other: FMD; Other: FMS; Other: FMDP

• Registration Number: NCT03509233
• Lead Sponsor: RWTH Aachen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-26
• Primary Completion: 2020-03-27
• Status Verified: 2020-08
• Study Completion: 2020-08-27
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Q-SRP	Q-SRP	Quadrant scaling and root planing
FMD	FMD	Full mouth disinfection
FMS	FMS	Full mouth scaling and root planing
FMDP	FMDP	Full mouth disinfection with periopolishing

Primary Outcome Measures

Name	Time	Method
Change of clinical attachment level	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 Outcome Measures

Name	Time	Method
Change of bleeding on probing	Baseline, 3 months, 6 months	Assessment of the change of the appearance of a bleeding spot immediately after the probing of periodontal pockets 3 and 6 months after therapy compared to baseline
Change of gingival index	Baseline, 3 months, 6 months	Recording the change of the presence of supragingival plaque according to the criteria by assessment of the inflammatory status of the gingiva according to Löe et al. 3 and 6 months after therapy compared to baseline
Change of pocket probing depth	Baseline, 3 months, 6 months	Measuring the change of the distance between the gingival sulcus and the bottom of the periodontal pocket 3 and 6 months after therapy compared to baseline
Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola	Baseline, 3 months, 6 months	Analysis of pooled subgingival plaque specimen for the presence of periodontopathogenic marker bacteria A. actinomycetemcomitans, P. gingivitis, T. forsythia and P. intermedia; Assessment of the change of the occurrence of these bacteria 3 and 6 months after therapy compared to baseline
Change of plaque index	Baseline, 3 months, 6 months	Recording the change of the presence of supragingival plaque according to the criteria by Silness and Loe 3 and 6 months after therapy compared to baseline

Trial Locations

Locations (5)

Department of Dental Medicine 1 (Periodontology); 🇷🇴 Timişoara, Romania

Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin; 🇩🇪 Berlin, Germany

Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde; 🇩🇪 Aachen, Germany

Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie; 🇩🇪 Halle (Saale), Germany

Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie; 🇩🇪 Mainz, Germany