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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002240 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash | Experimental | Participants with normal to dry mouth will first test a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours. After a washout period of at least 3 days, they will then test a Calcium mouthwash (150 milimolars of calcium) immediately before the Fluoride mouthwash, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours. |
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| Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash alone | Experimental | Participants with normal to dry mouth will first test a Calcium mouthwash (150 milimolars of calcium) immediately before a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours. After a washout period of at least 3 days, they will then test the Fluoride mouthwash alone, and fluoride concentration in saliva and dental biofilm will be assessed overtime for up to 2 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride mouthwash | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 15 minutes after mouthwash(es) |
| 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. | 60 minutes after mouthwash(es) |
| 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. | 120 minutes after mouthwash(es) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Fluoride Concentration in Saliva at 16 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Livia M Tenuta, DDS, MS, PhD | Associate Professor, University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry, University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluoride Mouthwash Alone, Then Calcium Mouthwash Before a Fluoride Mouthwash | Participants with normal to dry mouth first tested a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours. After a washout period of at least 3 days, they then tested a Calcium mouthwash (150 millimoles per liter of calcium) immediately before the Fluoride mouthwash, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours. |
| FG001 | Calcium Mouthwash Before a Fluoride Mouthwash, Then Fluoride Mouthwash Alone | Participants with normal to dry mouth first tested a Calcium mouthwash (150 millimoles per liter of calcium) immediately before a Fluoride mouthwash containing 226 ppm of fluoride, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours. After a washout period of at least 3 days, they then tested the Fluoride mouthwash alone, and fluoride concentration in saliva and dental biofilm was assessed overtime for up to 2 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | Baseline |
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Until 126 minutes after mouthwash(es) use.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluoride Mouthwash | Participants with normal salivary flow to dry mouth were treated, in a crossover design, with two interventions: a fluoride mouthwash alone, or a fluoride mouthwash preceded by a calcium mouthwash. Participants were randomized to determine which intervention they used in the first experimental phase; the other intervention will the tested in the second phase. This arm refers to the use of the fluoride mouthwash: Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), was used to rinse the mouth for 1 minute and expectorated. |
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The amount of biofilm collected from participants at the different time points was not enough for all the analyses planned in a number of occasions. This accounts for the lack of data for the calcium concentration in the biofilm fluid.
This experiment was conducted during the COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Livia Tenuta | University of Michigan School of Dentistry | 734-763-3703 | litenuta@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2020 | Mar 9, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2022 | Jan 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Calcium and fluoride mouthwash | Drug | 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. |
|
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| Baseline |
| 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. | 15 minutes after mouthwash(es) |
| 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. | 60 minutes after mouthwash(es) |
| 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. | 120 minutes after mouthwash(es) |
| 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). | Baseline, 15, 60 and 120 minutes after mouthwash(es) |
| 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). | Baseline, 15, 60 and 120 minutes after mouthwash |
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. |
| 16-21 minutes after mouthwash(es) |
| 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. | 30-35 minutes after mouthwash(es) |
| 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. | 61-66 minutes after mouthwash(es) |
| 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. | 90-95 minutes after mouthwash(es) |
| 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. | 121-126 minutes after mouthwash(es) |
| 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. | Baseline |
| 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. | 15 minutes after mouthwash(es) |
| 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. | 60 minutes after mouthwash(es) |
| 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. | 120 minutes after mouthwash(es) |
| 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. | Baseline |
| 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. | 15 minutes after mouthwash(es) |
| 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. | 60 minutes after mouthwash(es) |
| 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. | 120 minutes after mouthwash(es) |
| 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). | Baseline |
| 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). | 16-21 minutes after mouthwash(es) |
| 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). | 30-35 minutes after mouthwash(es) |
| 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). | 61-66 minutes after mouthwash(es) |
| 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). | 90-95 minutes after mouthwash(es) |
| 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). | 121-126 minutes after mouthwash(es) |
| 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. | Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es) |
| 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). | Baseline, 15, 60 and 120 minutes after mouthwash(es) |
| 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. | Baseline, 15, 60 and 120 minutes after mouthwash(es) |
| 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). | Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es) |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Unstimulated salivary flow rate, mL/min | Mean | Standard Deviation | mL/min |
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| Stimulated salivary flow rate, mL/min | Mean | Standard Deviation | mL/min |
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| OG001 | Calcium Mouthwash Before Fluoride Mouthwash | Participants with normal salivary flow to dry mouth were treated, in a crossover design, with two interventions: a fluoride mouthwash alone, or a fluoride mouthwash preceded by a calcium mouthwash. Participants were randomized to determine which intervention they used in the first experimental phase; the other intervention will the tested in the second phase. This arm refers to the use of the calcium mouthwash before the fluoride mouthwash: Calcium lactate, at a concentration of 150 millimolar, was 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), was used to rinse the mouth for 1 minute, and expectorated. |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 15 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 60 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 120 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms fluoride/milligram protein | Baseline |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms fluoride/milligram protein | 15 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms fluoride/miligram protein | 60 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms fluoride/miligram protein | 120 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Mean | Standard Deviation | parts per million x minutes | Baseline, 15, 60 and 120 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | microgram fluoride/milligram prot x min | Baseline, 15, 60 and 120 minutes after mouthwash |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | Baseline |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 16-21 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 30-35 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 61-66 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 90-95 minutes after mouthwash(es) |
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| 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million (ppm) of fluoride | 121-126 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Baseline |
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| 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. | 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. | Posted | 15 minutes after mouthwash(es) |
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| 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. | 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. | Posted | 60 minutes after mouthwash(es) |
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| 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. | 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. | Posted | 120 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms calcium/miligram protein | Baseline |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms calcium/miligram protein | 15 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms calcium/miligram protein | 60 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms calcium/miligram protein | 120 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Mean | Standard Deviation | milimolar | Baseline |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | milimolar | 16-21 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | milimolar | 30-35 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Mean | Standard Deviation | milimolar | 61-66 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | milimolar | 90-95 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Mean | Standard Deviation | milimolar | 121-126 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | parts per million x minutes | Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Baseline, 15, 60 and 120 minutes after mouthwash(es) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | micrograms calcium x time/milligram prot | Baseline, 15, 60 and 120 minutes after mouthwash(es) |
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| 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). | 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. | Posted | Mean | Standard Deviation | milimolar x minutes | Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es) |
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| 0 |
| 19 |
| 0 |
| 19 |
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| 19 |
| EG001 | Calcium Mouthwash Before Fluoride Mouthwash | Participants with normal salivary flow to dry mouth were treated, in a crossover design, with two interventions: a fluoride mouthwash alone, or a fluoride mouthwash preceded by a calcium mouthwash. Participants were randomized to determine which intervention they used in the first experimental phase; the other intervention will the tested in the second phase. This arm refers to the use of the calcium mouthwash before the fluoride mouthwash: Calcium lactate, at a concentration of 150 millimolar, was 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), was used to rinse the mouth for 1 minute, and expectorated. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |