Effect of Mouthrinsing on Inflammation of the Gums.

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Collaborator: Gaba International AG
• Treatments: Fluorides; Tin Fluorides

Criteria

Inclusion Criteria:

• Healthy male and female adults aged ≥18 years.

• Participants who have gingivitis/mild chronic periodontitis (approximal probing depth ≤ 3.5 mm at ≥ 80 % of the sites and at ≤ 20 % of the sites > 3.5 mm and < 5 mm).

• Participants must have read, understood and signed the informed consent form.

• Participants who have a GI ≥ 1.3 at baseline.

• Participants who have at least 20 own teeth excluding the wisdom teeth (incl. 16 natural crowns).

• Participants who have an acceptable compliance according to the investigators' assessment.

Exclusion Criteria:

• Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics).

• Participants who require antibiotic treatments for dental appointments (endocarditis prophylaxis).

• Participants who were treated with antibiotics 8 weeks before recruitment and during the course of the study.

• Participants who were treated with any antibacterial mouthrinse 6 weeks before recruitment.

• Participants who use other than the recommended mouthrinse or toothpaste during the study period.

• Participants who have moderate and severe chronic or aggressive periodontitis.

• Participants who have irregularities of the gingival tissues, e. g. hyperplastic gingiva, mucosal diseases.

• Participants who have rampant caries.

• Participants under guardianship or without freedom by administrative or legal award.

• Known hypersensitivity or allergy to the study product and standard toothpaste ingredients used in the present study.

• Known pregnancy or breast feeding during the course of the study.

• Participation in another clinical trial or receipt of an investigational compound/treatment at the same time and 4 weeks prior to inclusion.