Clinical study for the evaluation of the effectivity of different tooth brushes in inital treatment of periodontal diseased patients

Not Applicable

• Conditions: chronical periodontitis; K05.3; Chronic periodontitis

• Registration Number: DRKS00009642
• Lead Sponsor: Poliklinik für Zahnerhaltung und Parodontologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2010-12-31
• Study Start: 2016-08-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

•male/female patients with at least 20 natural teeth
•no professional tooth cleaning in the last 6 months
•requiring periodontal treatment, i.e., PSI/PSR code 3 and/or 4 in at least 2 sextants
•20% of teeth had a periodontal probing depth (PPD) larger than 4 mm (at least 1 in the maxilla and mandible)
•20% of teeth had attachment loss (CAL)larger than 4 mm
•patients with untreated chronic periodontitis and
•non-smokers

Exclusion Criteria

•Age <18 years
•having had an organ transplantation; immune suppression
•patients needing endocarditis prophylaxis
•patients with infectious disease including hepatitis A, B, C, TBC and HIV
•patients with renal insufficiency
•patients with neurological and/or cerebral seizure disorders
•addicts
•patients with known incompatibility/hypersensitivity
•pregnancy
•patients who underwent antibiotic therapy until 4 months before study start

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bleeding on probing (BOP), clinical assessment using a periodontal probe (PCP 15, Hu-Friedy, Chicago, IL, USA); evaluation at each investigation appointment.

Secondary Outcome Measures

Name	Time	Method
modified Quigley-Hein-Index: at each appointment after staining the plaque using erythrosine solution (Mira-2-Ton®, Hager & Werken GmbH & Co. KG, Duisburg, Germany) visually. Papilla Bleeding Index: at each appointment using the periodontal probe (PCP 15, Hi-Friedy, Chicago, IL, USA). recession and periodontal probing depth: at each appointment using the periodontal probe (PCP 15, Hi-Friedy, Chicago, IL, USA). microbiological findings: PCR analysis of 11 periodontal pathogenic bacteria from gingival crevicular fluid samples, which were taken from the deepest periodontal pockets at each appointment.