Fluoride Retention in the Mouth of Older Adults
Condition: Hyposalivation
MeSH terms: Xerostomia
Intervention: Fluoride mouthwash; Calcium and fluoride mouthwash
Intervention description: 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 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.
Intervention MeSH terms: Calcium, Dietary; Calcium; Fluorides
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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