NCT01317446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

March 16, 2011

Last Update Submit

January 16, 2012

Conditions

Gingivitis

Keywords

gingivitis indexplaque indexdiscoloration indexmouth rinseamine fluoride/stannous fluorideclinical trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Reduction in plaque

    6 months

  • Discoloration of teeth

    6 months

  • Bacterial colonization

    6 months

  • Adverse events

    6 months

Study Arms (2)

amine fluoride/stannous fluoride

EXPERIMENTAL

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

Drug: amine fluoride/stannous fluoride

No rinsing

NO INTERVENTION

Mechanical oral hygiene only

Interventions

amine fluoride/stannous fluorideDRUG

10 ml qd, oral, topical, 6 months duration

Also known as: meridol
amine fluoride/stannous fluoride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dreden University of Technology, Universitätsklinikum, Poliklinik für Parodontologie

Dresden, Saxony, 01109, Germany

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Tin FluoridesMeridol

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Thomas Hoffmann, Prof. Dr.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

November 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

DE(1)