Clinical trial NCT01317446: Effect of Mouthrinsing on Inflammation of the Gums.
Official title: Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Keywords: gingivitis index
plaque index
discoloration index
mouth rinse
amine fluoride/stannous fluoride
clinical trial
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Gaba International AG
First posted: 2011-03-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Gingivitis prevalence is 100% among the population. This is mostly due to an inadequate mechanical cleaning of the teeth. However, remaining dental biofilm can be approached by antibacterial mouthrinses. As a consequence of regular use of these mouthrinses, gingivitis can be reduced. Amine fluoride/stannous flouride mouthrinse (ASF)has proved its efficacy in several studies. In the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. Therefore, it is the aim of the study to proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. In addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.

Eligibility 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.

Primary outcomes:
measure: Reduction in gingivitis
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in plaque
timeFrame: 6 months
measure: Discoloration of teeth
timeFrame: 6 months
measure: Bacterial colonization
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
state: Sachsen
Study officials:
affiliation: Technische Universität Dresden
name: Thomas Hoffmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: