Anti-gingivitis Mouthrinse

Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study

The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.

Inclusion Criteria:

• Availability for the six-month duration of the clinical research study.
• Good general health.
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
• Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
• Signed Informed Consent Form.

Exclusion Criteria:

• Presence of orthodontic bands.
• Malign tumor(s) of the soft or hard tissues of the oral cavity.
• Antibiotic use any time during the one-month period prior to entry into the study.
• Participation in any other clinical study or test panel within the one month prior to entry into the study.
• Dental prophylaxis during the past two weeks prior to baseline examinations.
• History of allergies to oral care/personal care consumer products or their ingredients.
• On any prescription medicines that might interfere with the study outcome.
• An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Self-reported pregnant or lactating subjects.
• Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
• Participants who require antibiotic treatments for dental appointments.
• Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3).
• Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
• Smokers or/and users of tobacco products.
• Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)