Effect of Mouthrinsing on Inflammation of the Gums.

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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: amine fluoride/stannous fluoride

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Sachsen
    • Dresden, Sachsen, Germany, 01109
      • Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: meridol
No Intervention: No rinsing; Mechanical oral hygiene only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Discoloration of teeth	To proof the effect of rinsing with ASF on discoloration of teeth	6 months
Bacterial colonization	To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization	6 months
Adverse events	Recording all adverse events over the entire rinsing period	6 months

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Gaba International AG

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (Estimate): March 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 16, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: clinical trial; plaque index; gingivitis index; discoloration index; mouth rinse; amine fluoride/stannous fluoride
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides
• Other Study ID Numbers: GASAS-1007X