Antibacterial and anti-plaque effect and substantivity of different toothpaste slurries

Phase 4

• Conditions: bacterial dental plaque; K05.6; Periodontal disease, unspecified

• Registration Number: DRKS00023738
• Lead Sponsor: Klinik für Parodontologie und peri-implantäre Erkrankungen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-10-19
• Study Start: 2021-03-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

At the age between the age of 18-70 years; In good health; With least 20 own teeth (excluding wisdom teeth); Reassurement of an effective contraception; Non-smokers or former smokers for at least 1 year or occasional smokers with a maximum of 5 cigarettes per week; Willing not to use interdental cleaning devices that contain antibacterial agents, like amine fluoride, chlorhexidine, silver ions etc. during the full duration of the study.

Exclusion Criteria

1. Severe systemic diseases (e.g. tumours, infectious diseases) and diseases that require regular systemic drugs (e.g., Anti-Hypertensives: Ca-Antagonists); 2. The use of systemic antibiotics during the last 3 months or local antimicrobials that may affect the plaque biofilm (antibacterial mouth rinses (e. g. chlorhexidine) 4 weeks or less prior recruitment); 3. Severe oropharyngeal infections, significant dental disorders, ongoing dental treatment or any other medical treatment of the oral cavity; 4. Any known allergy to previously used oral hygiene products and/or oral therapeutic agents and/or dental materials or a known allergy to any of the ingredients of the study products or standard toothpaste (e.g. Limonene), which are used during the study and the wash-out periods; 5. Participants with current periodontitis or non-physiological tooth mobility, any other pathological change of the oral mucosa or gingiva, poor oral hygiene (papilla bleeding index PBI >30%); 6. Chronic drug abuse (alcohol, etc.) or any other illness which does not allow the person to assess the nature and/or possible consequences of the study; 7. Smoking with more than 5 cigarettes per week,; 8. Participation in another clinical study within the previous 30 days or parallel to this study; 9. dual participation in this or another clinical study during the clinical phase; 10. Individuals unwilling to abstain from additional oral hygiene measures during the treatment phase; 11. Non-Caucasians and women being pregnant or breast feeding.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vitality of dental plaque flora using vital fluorescence.<br>Biofilm vitality (VF) after 24 hours.

Secondary Outcome Measures

Name	Time	Method
Acceptance using Visual Analogue Scale (VAS) questionnaires.