Phase 1 N=20 Randomized Prevention

Fluoride Retention in the Mouth of Older Adults

Hyposalivation

Bottom Line

View on ClinicalTrials.gov: NCT04239872 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Fluoride Concentration in Dental Biofilm Fluid at Baseline — 0.24; 0.22 parts per million (ppm) of fluoride — p=0.8412

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Fluoride mouthwash (Drug); Calcium and fluoride mouthwash (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Fluoride Concentration in Dental Biofilm Fluid at Baseline	0.24; 0.22	0.8412
PRIMARY Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes	15.27; 12.29	0.6504
PRIMARY Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes	1.57; 4.07	0.0024 sig
PRIMARY Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes	0.63; 2.58	0.0013 sig
PRIMARY Fluoride Concentration in Dental Biofilm Solids at Baseline	0.17; 0.13	0.2041
PRIMARY Fluoride Concentration in Dental Biofilm Solids at 15 Minutes	0.44; 5.30	<0.0001 sig
PRIMARY Fluoride Concentration in Dental Biofilm Solids at 60 Minutes	0.23; 5.98	<0.0001 sig
PRIMARY Fluoride Concentration in Dental Biofilm Solids at 120 Minutes	0.18; 4.84	<0.0001 sig
PRIMARY Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime	841.6; 764.4	0.5543
PRIMARY Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime	37.85; 521.2	0.0003 sig
SECONDARY Fluoride Concentration in Saliva at Baseline	0.14; 0.11	0.2824
SECONDARY Fluoride Concentration in Saliva at 16 Minutes	4.60; 20.36	0.0002 sig
SECONDARY Fluoride Concentration in Saliva at 30 Minutes	2.18; 17.05	<0.0001 sig
SECONDARY Fluoride Concentration in Saliva at 61 Minutes	1.07; 9.98	<0.0001 sig
SECONDARY Fluoride Concentration in Saliva at 90 Minutes	0.80; 7.66	<0.0001 sig
SECONDARY Fluoride Concentration in Saliva at 121 Minutes	0.46; 3.71	<0.0001 sig
SECONDARY Calcium Concentration in Dental Biofilm Fluid at Baseline	—	—
SECONDARY Calcium Concentration in Dental Biofilm Fluid at 15 Minutes	—	—
SECONDARY Calcium Concentration in Dental Biofilm Fluid at 60 Minutes	—	—
SECONDARY Calcium Concentration in Dental Biofilm Fluid at 120 Minutes	—	—
SECONDARY Calcium Concentration in Dental Biofilm Solids at Baseline	5.74; 4.67	0.3283
SECONDARY Calcium Concentration in Dental Biofilm Solids at 15 Minutes	4.48; 8.88	0.0058 sig
SECONDARY Calcium Concentration in Dental Biofilm Solids at 60 Minutes	6.64; 12.4	0.0213 sig
SECONDARY Calcium Concentration in Dental Biofilm Solids at 120 Minutes	5.08; 9.66	0.014 sig
SECONDARY Calcium Concentration in Saliva at Baseline	1.57; 1.76	0.1393
SECONDARY Calcium Concentration in Saliva at 16 Minutes	1.14; 2.38	0.0009 sig
SECONDARY Calcium Concentration in Saliva at 30 Minutes	1.12; 2.03	0.0008 sig
SECONDARY Calcium Concentration in Saliva at 61 Minutes	1.62; 2.01	0.1515
SECONDARY Calcium Concentration in Saliva at 90 Minutes	1.50; 1.74	0.1712
SECONDARY Calcium Concentration in Saliva at 121 Minutes	1.60; 1.80	0.1188
SECONDARY Area Under the Curve of Fluoride Concentration in Saliva Overtime	186; 1415	<0.0001 sig
SECONDARY Area Under the Curve of Calcium Concentration in Dental Biofilm Fluid Overtime	—	—
SECONDARY Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime	780; 1165	0.0475 sig
SECONDARY Area Under the Curve of Calcium Concentration in Saliva Overtime	176; 242	0.0004 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04239872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.