Clinical trial NCT04239872: Fluoride Retention in the Mouth of Older Adults
Official title: Optimizing Fluoride Retention in the Mouth of Older Adults With Distinct Salivary Flow Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyposalivation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Fluoride Concentration in Dental Biofilm Fluid at Baseline
timeFrame: Baseline
measure: Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes
timeFrame: 15 minutes after mouthwash(es)
measure: Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes
timeFrame: 60 minutes after mouthwash(es)
measure: Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes
timeFrame: 120 minutes after mouthwash(es)
measure: Fluoride Concentration in Dental Biofilm Solids at Baseline
timeFrame: Baseline
measure: Fluoride Concentration in Dental Biofilm Solids at 15 Minutes
timeFrame: 15 minutes after mouthwash(es)
measure: Fluoride Concentration in Dental Biofilm Solids at 60 Minutes
timeFrame: 60 minutes after mouthwash(es)
measure: Fluoride Concentration in Dental Biofilm Solids at 120 Minutes
timeFrame: 120 minutes after mouthwash(es)
measure: Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime
timeFrame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
measure: Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime
timeFrame: Baseline, 15, 60 and 120 minutes after mouthwash
Secondary outcomes:
measure: Fluoride Concentration in Saliva at Baseline
timeFrame: Baseline
measure: Fluoride Concentration in Saliva at 16 Minutes
timeFrame: 16-21 minutes after mouthwash(es)
measure: Fluoride Concentration in Saliva at 30 Minutes
timeFrame: 30-35 minutes after mouthwash(es)
measure: Fluoride Concentration in Saliva at 61 Minutes
timeFrame: 61-66 minutes after mouthwash(es)
measure: Fluoride Concentration in Saliva at 90 Minutes
timeFrame: 90-95 minutes after mouthwash(es)
measure: Fluoride Concentration in Saliva at 121 Minutes
timeFrame: 121-126 minutes after mouthwash(es)
measure: Calcium Concentration in Dental Biofilm Fluid at Baseline
timeFrame: Baseline
measure: Calcium Concentration in Dental Biofilm Fluid at 15 Minutes
timeFrame: 15 minutes after mouthwash(es)
measure: Calcium Concentration in Dental Biofilm Fluid at 60 Minutes
timeFrame: 60 minutes after mouthwash(es)
measure: Calcium Concentration in Dental Biofilm Fluid at 120 Minutes
timeFrame: 120 minutes after mouthwash(es)
measure: Calcium Concentration in Dental Biofilm Solids at Baseline
timeFrame: Baseline
measure: Calcium Concentration in Dental Biofilm Solids at 15 Minutes
timeFrame: 15 minutes after mouthwash(es)
measure: Calcium Concentration in Dental Biofilm Solids at 60 Minutes
timeFrame: 60 minutes after mouthwash(es)
measure: Calcium Concentration in Dental Biofilm Solids at 120 Minutes
timeFrame: 120 minutes after mouthwash(es)
measure: Calcium Concentration in Saliva at Baseline
timeFrame: Baseline
measure: Calcium Concentration in Saliva at 16 Minutes
timeFrame: 16-21 minutes after mouthwash(es)
measure: Calcium Concentration in Saliva at 30 Minutes
timeFrame: 30-35 minutes after mouthwash(es)
measure: Calcium Concentration in Saliva at 61 Minutes
timeFrame: 61-66 minutes after mouthwash(es)
measure: Calcium Concentration in Saliva at 90 Minutes
timeFrame: 90-95 minutes after mouthwash(es)
measure: Calcium Concentration in Saliva at 121 Minutes
timeFrame: 121-126 minutes after mouthwash(es)
measure: Area Under the Curve of Fluoride Concentration in Saliva Overtime
timeFrame: Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es)
measure: Area Under the Curve of Calcium Concentration in Dental Biofilm Fluid Overtime
timeFrame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
measure: Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime
timeFrame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
measure: Area Under the Curve of Calcium Concentration in Saliva Overtime
timeFrame: Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: School of Dentistry, University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor, University of Michigan
name: Livia M Tenuta, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: