Fluoride Retention in the Mouth of Older Adults

University of Michigan

Status and phase: Completed; Phase 1

Conditions: Hyposalivation

Treatments: Drug: Fluoride mouthwash; Drug: Calcium and fluoride mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT04239872

UL1TR002240 (U.S. NIH Grant/Contract)

HUM00159624

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Good general health as evidenced by medical history
• Good oral health as evidenced by a clinical oral exam
• Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
• Having salivary flow rate ranging from normal to hyposalivation according to direct flow rate determination methods
• Agreement to adhere to the study protocol

Exclusion criteria

• Unable to understand and/or follow study instructions
• Active periodontitis
• Oral pain
• In need of urgent dental care

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Fluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash

Experimental group

Description:

Participants with normal to dry mouth will first test a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours. After a washout period of at least 3 days, they will then test a Calcium mouthwash (150 milimolars of calcium) immediately before the Fluoride mouthwash, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours.

Treatment:

Drug: Calcium and fluoride mouthwash

Drug: Fluoride mouthwash

Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash alone

Experimental group

Description:

Participants with normal to dry mouth will first test a Calcium mouthwash (150 milimolars of calcium) immediately before a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours. After a washout period of at least 3 days, they will then test the Fluoride mouthwash alone, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours.

Treatment:

Drug: Calcium and fluoride mouthwash

Drug: Fluoride mouthwash