CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Fluoride free toothpaste +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02399163
NCT02399163N/ACompleted

Clinical Evaluation of Oral Hygiene Products in an In Situ Caries Model

GlaxoSmithKline·interventional·Posted Mar 26, 2015·Updated May 12, 2016

In Brief

A clinical study evaluating Fluoride free toothpaste, Fluoride toothpaste, and 1 other intervention for Dental Caries. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR). This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 26, 2015
Enrollment StartApr 1, 2015
Primary CompletionJul 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.3 years ago

Interventions

Fluoride free toothpastedrug

Brushing with fluoride free toothpaste

Fluoride toothpastedrug

Brushing with fluoride containing toothpaste

Fluoride mouthwashdrug

Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in "Placebo dentifrice/Fluoride rinse" arm and in "Fluoride dentifrice/Fluoride rinse" arm