NCT04006470

Brief Summary

The aim of this 5 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices to assess enamel erosion protection in-situ using surface profilometry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P50-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
7 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

July 1, 2019

Last Update Submit

July 1, 2019

Conditions

Enamel Erosion

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Surface profilometry

    Enamel samples will be measured via profilometry after 10 days of study use.

    10 days

Study Arms (3)

Stannous Fluoride Dentifrice

Twice daily use

Drug: Stannous fluoride dentifrice

Positive control dentifrice

Twice daily use

Drug: Positive control dentifrice

Negative control dentifrice

Twice daily use

Drug: Negative control dentifrice

Interventions

Stannous fluoride dentifriceDRUG

Stannous fluoride (0.454%) dentifrice

Stannous Fluoride Dentifrice
Positive control dentifriceDRUG

Positive control dentifrice containing potassium nitrate or arginine.

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.

You may qualify if:

  • healthy subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple P&G Investigation Clinical Sites

Cincinnati, Ohio, 45040, United States

Location

Study Design

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

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

January 8, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

US(1)