Effect of Mouthrinsing on Inflammation of the Gums.

Gingivitis Clinical Trial

Official title:

Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317446
• Other study ID #: GASAS-1007X
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2011
• Last updated: January 16, 2012
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• amine fluoride/stannous fluoride
10 ml qd, oral, topical, 6 months duration

Locations

Country	Name	City	State
Germany	Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie	Dresden	Sachsen

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Gaba International AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in gingivitis	To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone.	6 months	No
Secondary	Reduction in plaque	To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on plaque reduction than mechanical oral hygiene alone.	6 months	No
Secondary	Discoloration of teeth	To proof the effect of rinsing with ASF on discoloration of teeth	6 months	No
Secondary	Bacterial colonization	To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization	6 months	No
Secondary	Adverse events	Recording all adverse events over the entire rinsing period	6 months	Yes