Effect of Mouthrinsing on Inflammation of the Gums.
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|ClinicalTrials.gov Identifier: NCT01317446|
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : January 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Drug: amine fluoride/stannous fluoride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||November 2010|
|Primary Completion Date :||January 2012|
|Study Completion Date :||January 2012|
Experimental: amine fluoride/stannous fluoride
Amine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene
Drug: amine fluoride/stannous fluoride
10 ml qd, oral, topical, 6 months duration
Other Name: meridol
No Intervention: No rinsing
Mechanical oral hygiene only
- Reduction in gingivitis [ Time Frame: 6 months ]To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone.
- Reduction in plaque [ Time Frame: 6 months ]To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on plaque reduction than mechanical oral hygiene alone.
- Discoloration of teeth [ Time Frame: 6 months ]To proof the effect of rinsing with ASF on discoloration of teeth
- Bacterial colonization [ Time Frame: 6 months ]To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization
- Adverse events [ Time Frame: 6 months ]Recording all adverse events over the entire rinsing period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317446
|Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie|
|Dresden, Sachsen, Germany, 01109|
|Principal Investigator:||Thomas Hoffmann, Prof. Dr.||Technische Universität Dresden|