Clinical evaluation of the efficacy of Shur breath (Sylphar) in the reduction of bad breath

Phase 4

Completed

• Conditions: R19.6; Halitosis

• Registration Number: DRKS00010618
• Lead Sponsor: Sylphar nv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-10
• Study Completion: 2017-05-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Age 18-65 , Halimeter ( InterScan ) measurement > 150ppb, Good knowledge of the German language to understand the subjects information education, Signed consent subjects

Exclusion Criteria

alcoholism, nicotine, pregnancy or lactation, participation in a clinical trial within the last 30 days, active caries, acute sinusitis, strong oropharyngeal infection, medicines can cause halitosis, reduced salivation, subjects eat the food very sharp, volunteers receiving homeopathic treatment, Taking antibiotics 2 months prior to study entry, eat frequent gum, subjects who do not comply with the study protocol, severe systemic disease, Known hypersensitivity to a substance used in the study, serious oral diseases , such as acute ulcerative gingivitis acute gingivostomatitis, orthodontic appliances

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is before the reduction of volatile sulfur compounds with the Halimeter® ( InterScan ) and proof of anti - adhesion anaerobic bacteria and after one or two weeks of use of the new product .<br>The differences tested ( before - after ) are using the variance analysis on significant group differences ( significance level 0.05 ) . Then alpha -adjusted , post-hoc tests are performed ( Holm - Bonferroni ) .<br>Depending on the distribution of data , statistical tests are applied ( SPSS version 22 )