drugset
drugset / Trial / NCT04239872

Fluoride Retention in the Mouth of Older Adults

NCT04239872 ↗

Phase 1 Completed 20 enrolled University of Michigan
RandomizedCrossoverOpen-labelPrevention

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.

Timeline

Start
2020-03-11
Primary completion
2021-04-05
Completion
2021-04-05

Outcome

Mixed primary results

registry analysis (superiority test); Fluoride Mouthwash vs Calcium Mouthwash Before Fluoride Mouthwash; p = 0.0024; Mean Difference (Net) 0.5307 (95% CI 0.2372 to 0.8243) NCT04239872 ↗

registry analysis (superiority test); Fluoride Mouthwash vs Calcium Mouthwash Before Fluoride Mouthwash; p = 0.8412; Mean Difference (Net) -0.00778 (95% CI -0.09209 to 0.07653) NCT04239872 ↗

registry analysis (superiority test); Fluoride Mouthwash vs Calcium Mouthwash Before Fluoride Mouthwash; p <0.0001; Mean Difference (Net) 1.095 (95% CI 0.7736 to 1.416) NCT04239872 ↗

registry analysis (superiority test); Fluoride Mouthwash vs Calcium Mouthwash Before Fluoride Mouthwash; p = 0.5543; Mean Difference (Net) -115.6 (95% CI -584.8 to 353.6) NCT04239872 ↗

registry analysis (superiority test); Fluoride Mouthwash vs Calcium Mouthwash Before Fluoride Mouthwash; p = 0.0003; Mean Difference (Net) 1.328 (95% CI 0.8420 to 1.814) NCT04239872 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcium lactate Small molecule 150 mmol Oral
Subject sodium fluoride Unknown 226 ppm Oral

Indications

No indication recorded.