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Effect of Mouthrinsing on Inflammation of the Gums.

Primary Purpose

Gingivitis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
amine fluoride/stannous fluoride
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring gingivitis index, plaque index, discoloration index, mouth rinse, amine fluoride/stannous fluoride, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

amine fluoride/stannous fluoride

No rinsing

Arm Description

Amine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene

Mechanical oral hygiene only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Discoloration of teeth
To proof the effect of rinsing with ASF on discoloration of teeth
Bacterial colonization
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization
Adverse events
Recording all adverse events over the entire rinsing period

Full Information

First Posted
March 16, 2011
Last Updated
January 16, 2012
Sponsor
Technische Universität Dresden
Collaborators
Gaba International AG
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1. Study Identification

Unique Protocol Identification Number
NCT01317446
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Gaba International AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
gingivitis index, plaque index, discoloration index, mouth rinse, amine fluoride/stannous fluoride, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
amine fluoride/stannous fluoride
Arm Type
Experimental
Arm Description
Amine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene
Arm Title
No rinsing
Arm Type
No Intervention
Arm Description
Mechanical oral hygiene only
Intervention Type
Drug
Intervention Name(s)
amine fluoride/stannous fluoride
Other Intervention Name(s)
meridol
Intervention Description
10 ml qd, oral, topical, 6 months duration
Primary Outcome Measure Information:
Title
Reduction in gingivitis
Description
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction in plaque
Description
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on plaque reduction than mechanical oral hygiene alone.
Time Frame
6 months
Title
Discoloration of teeth
Description
To proof the effect of rinsing with ASF on discoloration of teeth
Time Frame
6 months
Title
Bacterial colonization
Description
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene influences bacterial colonization
Time Frame
6 months
Title
Adverse events
Description
Recording all adverse events over the entire rinsing period
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hoffmann, Prof. Dr.
Organizational Affiliation
Technische Universität Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01109
Country
Germany

12. IPD Sharing Statement

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Effect of Mouthrinsing on Inflammation of the Gums.

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