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

Periodontitis Clinical Trial

Official title:

Anti-infectious Therapy of Chronic Periodontitis Using One Stage Full Mouth Disinfection With Subgingival Airpolishing - a Comparison of Different Clinical Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509233
• Other study ID #: RWTHAachenUParo01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 27, 2020

Study information

• Verified date: August 2020
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: August 27, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Q-SRP
Quadrant scaling and root planing under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within four sessions in intervals of 1 week
• FMS
Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours
• FMD
Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours with additional disinfection using 0.2% chlorhexidine (mouth rinsing and tonsil spray), subgingival application of 1% chlorhexidine gel and 2 months postoperative home care using chlorhexidine 0.2% (rinse and spray)
• FMDP
FMD protocol (see FMD arm) with additional use of subgingival airpolishing (Air Flow, EMS) using Erythritol powder (Air-Flow Plus powder, EMS) for 20 seconds per tooth

Locations

Country	Name	City	State
Germany	Universitätsklinikum RWTH Aachen, Klinik für Zahnerhaltung, Parodontologie u. Präventive Zahnheilkunde	Aachen
Germany	Charité Centrum Zahn-, Mund- und Kieferheilkunde, Parodontologie und Synoptische Zahnmedizin	Berlin
Germany	Universitätspoliklinik für Zahnerhaltungskunde und Parodontologie	Halle (Saale)
Germany	Universitätsmedizin Mainz, Poliklinik f. Zahnerhaltung u. Parodontologie	Mainz
Romania	Department of Dental Medicine 1 (Periodontology)	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Countries where clinical trial is conducted

Germany,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of clinical attachment level	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	Baseline, 3 months, 6 months
Secondary	Change of pocket probing depth	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	Baseline, 3 months, 6 months
Secondary	Change of presence of periodontopathogenic bacteria A. actinomycetemcomitans, P. gingivalis, P. intermedia and T. denticola	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	Baseline, 3 months, 6 months
Secondary	Change of bleeding on probing	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	Baseline, 3 months, 6 months
Secondary	Change of gingival index	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	Baseline, 3 months, 6 months
Secondary	Change of plaque index	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	Baseline, 3 months, 6 months