Effect of Mouthrinsing on Inflammation of the Gums.

This study has been completed.
Sponsor:
Collaborator:
Gaba International AG
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01317446
First received: March 16, 2011
Last updated: January 16, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Gingivitis
Drug: amine fluoride/stannous fluoride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months.

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Reduction in gingivitis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone.


Secondary Outcome Measures:
  • Reduction in plaque [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To proof the effect of rinsing with ASF on discoloration of teeth

  • Bacterial colonization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization

  • Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Recording all adverse events over the entire rinsing period


Enrollment: 180
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317446

Locations
Germany
Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
Dresden, Sachsen, Germany, 01109
Sponsors and Collaborators
Technische Universität Dresden
Gaba International AG
Investigators
Principal Investigator: Thomas Hoffmann, Prof. Dr. Technische Universität Dresden
  More Information

No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01317446     History of Changes
Other Study ID Numbers: GASAS-1007X
Study First Received: March 16, 2011
Last Updated: January 16, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
gingivitis index
plaque index
discoloration index
mouth rinse
amine fluoride/stannous fluoride
clinical trial

Additional relevant MeSH terms:
Inflammation
Gingivitis
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014