Overview

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.