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Fluoride Retention in the Mouth of Older Adults
Phase 1 trial testing Fluoride mouthwash in Hyposalivation in 20 participants. Completed in 5 April 2021.
| Lead sponsor | University of Michigan |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 11 March 2020 |
| Primary completion | 5 April 2021 |
| Estimated completion | 5 April 2021 |
| Sites | 1 location across United States |
University of Michigan
65 and older, any sex, with Hyposalivation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dental biofilm was collected at baseline (before mouthwash(es)), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis.
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 0.24 | 0.18 – 0.32 |
| Calcium Mouthwash Before Fluoride Mouthwash | 0.22 | 0.17 – 0.29 |
Dental biofilm was collected 15 minutes after mouthwash(es), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis.
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 15.27 | 7.84 – 29.76 |
| Calcium Mouthwash Before Fluoride Mouthwash | 12.29 | 9.46 – 15.98 |
Dental biofilm was collected 60 minutes after mouthwash(es), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis.
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 1.57 | 0.79 – 3.11 |
| Calcium Mouthwash Before Fluoride Mouthwash | 4.07 | 2.63 – 6.31 |
Dental biofilm was collected 120 minutes after mouthwash(es), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis.
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 0.63 | 0.40 – 0.99 |
| Calcium Mouthwash Before Fluoride Mouthwash | 2.58 | 1.33 – 5.00 |
Dental biofilm was collected at baseline (before mouthwash(es)). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lo
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 0.17 | 0.09 – 0.32 |
| Calcium Mouthwash Before Fluoride Mouthwash | 0.13 | 0.07 – 0.24 |
Dental biofilm was collected 15 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lowry
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 0.44 | 0.27 – 0.73 |
| Calcium Mouthwash Before Fluoride Mouthwash | 5.30 | 3.87 – 7.27 |
Dental biofilm will be collected 60 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lo
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 0.23 | 0.10 – 0.53 |
| Calcium Mouthwash Before Fluoride Mouthwash | 5.98 | 4.36 – 8.21 |
Dental biofilm was collected 120 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of fluoride reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Fluoride concentration in the dental biofilm solids acid extract was measured using an ion-specific electrode adapted for microanalysis; protein concentration in the alkali extract was determined using the Lowry
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 0.18 | 0.08 – 0.40 |
| Calcium Mouthwash Before Fluoride Mouthwash | 4.84 | 3.61 – 6.49 |
Fluoride concentration in dental biofilm fluid collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in dental biofilm fluid as a function of time (parts per million x min).
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 841.6 | ± 543.2 |
| Calcium Mouthwash Before Fluoride Mouthwash | 764.4 | ± 234.1 |
Fluoride concentration in dental biofilm solids collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in dental biofilm solids as a function of time (micrograms of fluoride x minutes/ milligram of proteins).
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 37.85 | 18.33 – 78.14 |
| Calcium Mouthwash Before Fluoride Mouthwash | 521.2 | 376.7 – 721.2 |
Unstimulated saliva was collected at baseline (before mouthwash(es)), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 0.14 | 0.09 – 0.21 |
| Calcium Mouthwash Before Fluoride Mouthwash | 0.11 | 0.09 – 0.13 |
Unstimulated saliva was collected 16 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.
| Group | Value | 95% CI |
|---|---|---|
| Fluoride Mouthwash | 4.60 | 2.70 – 7.81 |
| Calcium Mouthwash Before Fluoride Mouthwash | 20.36 | 15.08 – 27.48 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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