Hyposalivation
Conditions
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.
Interventions
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.
DRUGCalcium and fluoride mouthwash
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluoride Concentration in Dental Biofilm Fluid at Baseline | Baseline | 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. |
| Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes | 15 minutes after mouthwash(es) | 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. |
| Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes | 60 minutes after mouthwash(es) | 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. |
| Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes | 120 minutes after mouthwash(es) | 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. |
| Fluoride Concentration in Dental Biofilm Solids at Baseline | Baseline | 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 Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. |
| Fluoride Concentration in Dental Biofilm Solids at 15 Minutes | 15 minutes after mouthwash(es) | 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 colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. |
| Fluoride Concentration in Dental Biofilm Solids at 60 Minutes | 60 minutes after mouthwash(es) | 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 Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. |
| Fluoride Concentration in Dental Biofilm Solids at 120 Minutes | 120 minutes after mouthwash(es) | 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 colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein. |
| Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime | Baseline, 15, 60 and 120 minutes after mouthwash(es) | 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). |
| Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime | Baseline, 15, 60 and 120 minutes after mouthwash | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calcium Concentration in Dental Biofilm Solids at Baseline | Baseline | 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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. |
| Calcium Concentration in Dental Biofilm Solids at 15 Minutes | 15 minutes after mouthwash(es) | 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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. |
| Calcium Concentration in Dental Biofilm Solids at 60 Minutes | 60 minutes after mouthwash(es) | Dental biofilm was 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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. |
| Calcium Concentration in Dental Biofilm Solids at 120 Minutes | 120 minutes after mouthwash(es) | 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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein. |
| Calcium Concentration in Saliva at Baseline | Baseline | Unstimulated saliva was collected at baseline (before mouthwash(es)), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). |
| Calcium Concentration in Saliva at 16 Minutes | 16-21 minutes after mouthwash(es) | Unstimulated saliva was collected at 16 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). |
| Calcium Concentration in Saliva at 30 Minutes | 30-35 minutes after mouthwash(es) | Unstimulated saliva was collected at 30 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). |
| Fluoride Concentration in Saliva at Baseline | Baseline | 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. |
| Calcium Concentration in Saliva at 90 Minutes | 90-95 minutes after mouthwash(es) | Unstimulated saliva was collected at 90 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). |
| Calcium Concentration in Saliva at 121 Minutes | 121-126 minutes after mouthwash(es) | Unstimulated saliva was collected at 121 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). |
| Area Under the Curve of Fluoride Concentration in Saliva Overtime | Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es) | Fluoride concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in saliva as a function of time. |
| Area Under the Curve of Calcium Concentration in Dental Biofilm Fluid Overtime | Baseline, 15, 60 and 120 minutes after mouthwash(es) | Calcium concentration in dental biofilm fluid collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) will be expressed as the area under the curve of calcium concentration in dental biofilm fluid as a function of time (millimolar x min). |
| Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime | Baseline, 15, 60 and 120 minutes after mouthwash(es) | Calcium 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 calcium concentration in dental biofilm solids as a function of time. |
| Area Under the Curve of Calcium Concentration in Saliva Overtime | Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es) | Calcium concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of calcium concentration in saliva as a function of time (millimolar x min). |
| Calcium Concentration in Saliva at 61 Minutes | 61-66 minutes after mouthwash(es) | Unstimulated saliva was collected at 61 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III). |
| Fluoride Concentration in Saliva at 16 Minutes | 16-21 minutes after mouthwash(es) | 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. |
| Fluoride Concentration in Saliva at 30 Minutes | 30-35 minutes after mouthwash(es) | Unstimulated saliva was collected 30 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. |
| Fluoride Concentration in Saliva at 61 Minutes | 61-66 minutes after mouthwash(es) | Unstimulated saliva was collected 61 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. |
| Fluoride Concentration in Saliva at 90 Minutes | 90-95 minutes after mouthwash(es) | Unstimulated saliva was collected 90 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. |
| Fluoride Concentration in Saliva at 121 Minutes | 121-126 minutes after mouthwash(es) | Unstimulated saliva was collected 121 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis. |
| Calcium Concentration in Dental Biofilm Fluid at Baseline | Baseline | Dental biofilm will be collected at baseline (before mouthwash(es)), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar. |
| Calcium Concentration in Dental Biofilm Fluid at 15 Minutes | 15 minutes after mouthwash(es) | Dental biofilm will be collected 15 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar. |
| Calcium Concentration in Dental Biofilm Fluid at 60 Minutes | 60 minutes after mouthwash(es) | Dental biofilm will be collected 60 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar. |
| Calcium Concentration in Dental Biofilm Fluid at 120 Minutes | 120 minutes after mouthwash(es) | Dental biofilm will be collected 120 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Normal Salivary Flow to Dry Mouth Participants were randomly assigned to two arms, with varying sequence of treatment used, under a crossover design: Fluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash; OR Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash alone
Fluoride mouthwash consisted of Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), used to rinse the mouth for 1 minute and expectorated.
Calcium and fluoride mouthwash: Calcium lactate, at a concentration of 150 millimoles per liter, 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), used to rinse the mouth for 1 minute, and expectorated. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Participants With Normal Salivary Flow to Dry Mouth |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 70.9 years STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
| Stimulated salivary flow rate, mL/min | 1.21 mL/min STANDARD_DEVIATION 0.87 |
| Unstimulated salivary flow rate, mL/min | 0.3 mL/min STANDARD_DEVIATION 0.33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime
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).
Time frame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
Population: The area under the curve was calculated only for participants with all time points collected. This accounts for the smaller number of participants analyzed for this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Mouthwash | Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime | 841.6 parts per million x minutes | Standard Deviation 543.2 |
| Calcium Mouthwash Before Fluoride Mouthwash | Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime | 764.4 parts per million x minutes | Standard Deviation 234.1 |
Comparison: A paired t-test was used to compare the two groups.p-value: 0.554395% CI: [-584.8, 353.6]t-test, 2 sided
Primary
Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime
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).
Time frame: Baseline, 15, 60 and 120 minutes after mouthwash
Population: The area under the curve was calculated only for participants with all time points collected. This accounts for the smaller number of participants analyzed for this variable.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime | 37.85 microgram fluoride/milligram prot x min |
| Calcium Mouthwash Before Fluoride Mouthwash | Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime | 521.2 microgram fluoride/milligram prot x min |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.000395% CI: [0.842, 1.814]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes
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.
Time frame: 120 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes | 0.63 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes | 2.58 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.001395% CI: [0.2938, 0.8348]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes
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.
Time frame: 15 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes | 15.27 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes | 12.29 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.650495% CI: [-0.3955, 0.2573]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes
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.
Time frame: 60 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes | 1.57 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes | 4.07 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.002495% CI: [0.2372, 0.8243]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Fluid at Baseline
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.
Time frame: Baseline
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at Baseline | 0.24 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Fluid at Baseline | 0.22 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.841295% CI: [-0.09209, 0.07653]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Solids at 120 Minutes
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 colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein.
Time frame: 120 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at 120 Minutes | 0.18 micrograms fluoride/miligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at 120 Minutes | 4.84 micrograms fluoride/miligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [1.081, 2.017]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Solids at 15 Minutes
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 colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein.
Time frame: 15 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at 15 Minutes | 0.44 micrograms fluoride/milligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at 15 Minutes | 5.30 micrograms fluoride/milligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [0.7736, 1.416]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Solids at 60 Minutes
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 Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein.
Time frame: 60 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at 60 Minutes | 0.23 micrograms fluoride/miligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at 60 Minutes | 5.98 micrograms fluoride/miligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [1.112, 1.825]t-test, 2 sided
Primary
Fluoride Concentration in Dental Biofilm Solids at Baseline
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 Lowry colorimetric method. Fluoride concentration in the biofilm was expressed as micrograms of fluoride/milligrams of protein.
Time frame: Baseline
Population: A smaller number of participants analyzed for this variable means that they did not have sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at Baseline | 0.17 micrograms fluoride/milligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Dental Biofilm Solids at Baseline | 0.13 micrograms fluoride/milligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.204195% CI: [-0.2964, 0.06929]t-test, 2 sided
Secondary
Area Under the Curve of Calcium Concentration in Dental Biofilm Fluid Overtime
Calcium concentration in dental biofilm fluid collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) will be expressed as the area under the curve of calcium concentration in dental biofilm fluid as a function of time (millimolar x min).
Time frame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
Population: Due to the small amount of biofilm collected from participants, resulting in a reduced biofilm fluid volume, there was not enough sample left for calcium measurement after fluoride concentration in the fluid was determined. Therefore, the area under the curve could not be estimated for this variable.
Secondary
Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime
Calcium 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 calcium concentration in dental biofilm solids as a function of time.
Time frame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
Population: The area under the curve was calculated only for participants with all time points collected. This accounts for the smaller number of participants analyzed for this variable.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime | 780 micrograms calcium x time/milligram prot |
| Calcium Mouthwash Before Fluoride Mouthwash | Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime | 1165 micrograms calcium x time/milligram prot |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.047595% CI: [0.004686, 0.6351]t-test, 2 sided
Secondary
Area Under the Curve of Calcium Concentration in Saliva Overtime
Calcium concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of calcium concentration in saliva as a function of time (millimolar x min).
Time frame: Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es)
Population: The area under the curve was calculated only for participants with all time points collected. This accounts for the smaller number of participants analyzed for this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Mouthwash | Area Under the Curve of Calcium Concentration in Saliva Overtime | 176 milimolar x minutes | Standard Deviation 46.5 |
| Calcium Mouthwash Before Fluoride Mouthwash | Area Under the Curve of Calcium Concentration in Saliva Overtime | 242 milimolar x minutes | Standard Deviation 63.8 |
Comparison: A paired t-test was used to compare the two groups.p-value: 0.000495% CI: [27.46, 73.3]t-test, 2 sided
Secondary
Area Under the Curve of Fluoride Concentration in Saliva Overtime
Fluoride concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in saliva as a function of time.
Time frame: Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es)
Population: The area under the curve was calculated only for participants with all time points collected. This accounts for the smaller number of participants analyzed for this variable.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Area Under the Curve of Fluoride Concentration in Saliva Overtime | 186 parts per million x minutes |
| Calcium Mouthwash Before Fluoride Mouthwash | Area Under the Curve of Fluoride Concentration in Saliva Overtime | 1415 parts per million x minutes |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [0.7205, 1.071]t-test, 2 sided
Secondary
Calcium Concentration in Dental Biofilm Fluid at 120 Minutes
Dental biofilm will be collected 120 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar.
Time frame: 120 minutes after mouthwash(es)
Population: Due to the small amount of biofilm collected from participants, resulting in a reduced biofilm fluid volume, there was not enough sample left for calcium measurement after fluoride concentration in the fluid was determined.
Secondary
Calcium Concentration in Dental Biofilm Fluid at 15 Minutes
Dental biofilm will be collected 15 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar.
Time frame: 15 minutes after mouthwash(es)
Population: Due to the small amount of biofilm collected from participants, resulting in a reduced biofilm fluid volume, there was not enough sample left for calcium measurement after fluoride concentration in the fluid was determined.
Secondary
Calcium Concentration in Dental Biofilm Fluid at 60 Minutes
Dental biofilm will be collected 60 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar.
Time frame: 60 minutes after mouthwash(es)
Population: Due to the small amount of biofilm collected from participants, resulting in a reduced biofilm fluid volume, there was not enough sample left for calcium measurement after fluoride concentration in the fluid was determined.
Secondary
Calcium Concentration in Dental Biofilm Fluid at Baseline
Dental biofilm will be collected at baseline (before mouthwash(es)), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar.
Time frame: Baseline
Population: Due to the small amount of biofilm collected from participants, resulting in a reduced biofilm fluid volume, there was not enough sample left for calcium measurement after fluoride concentration in the fluid was determined.
Secondary
Calcium Concentration in Dental Biofilm Solids at 120 Minutes
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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein.
Time frame: 120 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at 120 Minutes | 5.08 micrograms calcium/miligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at 120 Minutes | 9.66 micrograms calcium/miligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.01495% CI: [0.07454, 0.5495]t-test, 2 sided
Secondary
Calcium Concentration in Dental Biofilm Solids at 15 Minutes
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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein.
Time frame: 15 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at 15 Minutes | 4.48 micrograms calcium/miligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at 15 Minutes | 8.88 micrograms calcium/miligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.005895% CI: [0.1189, 0.5633]t-test, 2 sided
Secondary
Calcium Concentration in Dental Biofilm Solids at 60 Minutes
Dental biofilm was 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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein.
Time frame: 60 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at 60 Minutes | 6.64 micrograms calcium/miligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at 60 Minutes | 12.4 micrograms calcium/miligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.021395% CI: [0.05266, 0.5426]t-test, 2 sided
Secondary
Calcium Concentration in Dental Biofilm Solids at Baseline
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 calcium 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. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein.
Time frame: Baseline
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at Baseline | 5.74 micrograms calcium/miligram protein |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Dental Biofilm Solids at Baseline | 4.67 micrograms calcium/miligram protein |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.328395% CI: [-0.1762, 0.06829]t-test, 2 sided
Secondary
Calcium Concentration in Saliva at 121 Minutes
Unstimulated saliva was collected at 121 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).
Time frame: 121-126 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Saliva at 121 Minutes | 1.60 milimolar | Standard Deviation 0.57 |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Saliva at 121 Minutes | 1.80 milimolar | Standard Deviation 0.59 |
Comparison: A paired t-test was used to compare the two groups.p-value: 0.118895% CI: [-0.07934, 0.6371]t-test, 2 sided
Secondary
Calcium Concentration in Saliva at 16 Minutes
Unstimulated saliva was collected at 16 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).
Time frame: 16-21 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Saliva at 16 Minutes | 1.14 milimolar |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Saliva at 16 Minutes | 2.38 milimolar |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.000995% CI: [0.1414, 0.4427]t-test, 2 sided
Secondary
Calcium Concentration in Saliva at 30 Minutes
Unstimulated saliva was collected at 30 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).
Time frame: 30-35 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Saliva at 30 Minutes | 1.12 milimolar |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Saliva at 30 Minutes | 2.03 milimolar |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.000895% CI: [0.1195, 0.3671]t-test, 2 sided
Secondary
Calcium Concentration in Saliva at 61 Minutes
Unstimulated saliva was collected at 61 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).
Time frame: 61-66 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Saliva at 61 Minutes | 1.62 milimolar | Standard Deviation 0.6 |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Saliva at 61 Minutes | 2.01 milimolar | Standard Deviation 0.6 |
Comparison: A paired t-test was used to compare the two groups.p-value: 0.151595% CI: [-0.1356, 0.7969]t-test, 2 sided
Secondary
Calcium Concentration in Saliva at 90 Minutes
Unstimulated saliva was collected at 90 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).
Time frame: 90-95 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Saliva at 90 Minutes | 1.50 milimolar |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Saliva at 90 Minutes | 1.74 milimolar |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.171295% CI: [-0.02327, 0.1203]t-test, 2 sided
Secondary
Calcium Concentration in Saliva at Baseline
Unstimulated saliva was collected at baseline (before mouthwash(es)), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).
Time frame: Baseline
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Mouthwash | Calcium Concentration in Saliva at Baseline | 1.57 milimolar | Standard Deviation 0.64 |
| Calcium Mouthwash Before Fluoride Mouthwash | Calcium Concentration in Saliva at Baseline | 1.76 milimolar | Standard Deviation 0.64 |
Comparison: A paired t-test was used to compare the two groups.p-value: 0.139395% CI: [-0.09153, 0.5962]t-test, 2 sided
Secondary
Fluoride Concentration in Saliva at 121 Minutes
Unstimulated saliva was collected 121 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.
Time frame: 121-126 minutes after mouthwash(es)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Saliva at 121 Minutes | 0.46 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Saliva at 121 Minutes | 3.71 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [0.6573, 1.179]t-test, 2 sided
Secondary
Fluoride Concentration in Saliva at 16 Minutes
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.
Time frame: 16-21 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Saliva at 16 Minutes | 4.60 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Saliva at 16 Minutes | 20.36 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.000295% CI: [0.3488, 0.905]t-test, 2 sided
Secondary
Fluoride Concentration in Saliva at 30 Minutes
Unstimulated saliva was collected 30 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.
Time frame: 30-35 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Saliva at 30 Minutes | 2.18 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Saliva at 30 Minutes | 17.05 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [0.6671, 1.122]t-test, 2 sided
Secondary
Fluoride Concentration in Saliva at 61 Minutes
Unstimulated saliva was collected 61 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.
Time frame: 61-66 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Saliva at 61 Minutes | 1.07 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Saliva at 61 Minutes | 9.98 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [0.7597, 1.186]t-test, 2 sided
Secondary
Fluoride Concentration in Saliva at 90 Minutes
Unstimulated saliva was collected 90 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.
Time frame: 90-95 minutes after mouthwash(es)
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Saliva at 90 Minutes | 0.80 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Saliva at 90 Minutes | 7.66 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: <0.000195% CI: [0.7758, 1.19]t-test, 2 sided
Secondary
Fluoride Concentration in Saliva at Baseline
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.
Time frame: Baseline
Population: A smaller number of participants analyzed for this variable means that they did not have a sample collected at this time point, or that the amount collected was not enough for the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Fluoride Mouthwash | Fluoride Concentration in Saliva at Baseline | 0.14 parts per million (ppm) of fluoride |
| Calcium Mouthwash Before Fluoride Mouthwash | Fluoride Concentration in Saliva at Baseline | 0.11 parts per million (ppm) of fluoride |
Comparison: A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.p-value: 0.282495% CI: [-0.2613, 0.08082]t-test, 2 sided