Anti-gingivitis Mouthrinse

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Fluorides

Criteria

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)