CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Fluoride mouthwash +1 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/NCT04239872
NCT04239872Phase 1Completed

Optimizing Fluoride Retention in the Mouth of Older Adults With Distinct Salivary Flow Rates

University of Michigan·interventional·Posted Jan 27, 2020·Updated Jan 31, 2023

In Brief

A Phase 1 clinical trial evaluating Fluoride mouthwash and Calcium and fluoride mouthwash for Hyposalivation. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Individuals with dry mouth (a reduction in the production of saliva) suffer from high rates of oral diseases. Dry mouth is a common problem among older individuals, because many medications to control chronic conditions (such as blood pressure, bladder-control problems and depression) reduce the flow of saliva. For these individuals, fluoride is used to maintain a good oral health. Usually, higher fluoride concentration products, such as prescription toothpastes, are recommended. In this project, the ability to increase fluoride retention in the mouth by using calcium before a conventional fluoride rinse will be tested in older adults with a range of salivary flow rates. This approach was never tested in patients with dry mouth, for whom the treatment with calcium may also be beneficial. A crossover, clinical study with two experimental phases will be conducted, in which patients with a range of saliva flows (from normal to dry mouth) will rinse with a fluoride rinse only (used at over the counter concentration), or a fluoride rinse preceded by a calcium rinse. The concentration of fluoride and calcium in the saliva and dental plaque residues will be determined up to two hours after the rinse(s), to test the effect of the approach to optimize fluoride retention in the mouth of patients with dry mouth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyposalivation
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 27, 2020
Enrollment StartMar 11, 2020
Primary CompletionApr 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.4 years ago

Interventions

Fluoride mouthwashdrug

Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), will be used to rinse the mouth for 1 minute and expectorated.

Calcium and fluoride mouthwashdrug

Calcium lactate, at a concentration of 150 milimolar, will be used to rinse the mouth for 1 minute and expectorated; immediately after, a sodium fluoride rinse, at a concentration of 0.05% (226 ppm of fluoride), will be used to rinse the mouth for 1 minute, and expectorated.