NCT03970759

Brief Summary

The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on gingivitis relative to a positive or negative control dentifrice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,890

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

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

January 8, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

May 29, 2019

Last Update Submit

June 13, 2019

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • Number of Bleeding Sites

    Change from baseline as measured on number of bleeding sites (gingival bleeding index or Loe Silness index).

    Up to 12 Weeks

Study Arms (3)

Stannous Fluoride Dentifrice

Twice daily brushing

Drug: Stannous Fluoride Dentifrice

Positive Control Dentifrice

Twice daily brushing

Drug: Positive control dentifrice

Negative Control Dentifrice

Twice daily brushing

Drug: Negative control dentifrice

Interventions

Stannous Fluoride DentifriceDRUG

Experimental stannous fluoride (0.454%) dentifrice

Stannous Fluoride Dentifrice
Positive control dentifriceDRUG

Positive control dentifrice containing (0.3%) triclosan.

Positive Control Dentifrice
Negative control dentifriceDRUG

Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)

Negative Control Dentifrice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This meta-analysis includes healthy adult male and females with mild-moderate gingivitis.

Subjects were excluded from this study for the following reasons; * pregnancy, * rampant caries, * severe periodontitis, * at discretionary of the Principal Investigator.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Multiple P&G Investigation Clinical Sites

Cincinnati, Ohio, 45040, United States

Location

Related Publications (1)

  • Biesbrock A, He T, DiGennaro J, Zou Y, Ramsey D, Garcia-Godoy F. The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials. J Clin Periodontol. 2019 Dec;46(12):1205-1216. doi: 10.1111/jcpe.13203.

    PMID: 31562774DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

June 3, 2019

Study Start

January 8, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

June 17, 2019

Record last verified: 2019-06

Locations

US(1)