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
Drug: amine fluoride/stannous fluoride
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01317446
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01317446
Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
Dresden, Sachsen, Germany, 01109
View full eligibility
Tris trial is registered with FDA with number: NCT01317446. The sponsor of the trial is Technische Universität Dresden and it is looking for 180 volunteers for the current phase.
Official trial title: Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months.
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