Trial · NCT04239872
Fluoride Retention in the Mouth of Older Adults
NCT04239872, Phase 1, Completed, University of Michigan; results first posted 2022-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fluoride Retention in the Mouth of Older Adults. Trials, record NCT04239872. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04239872
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fluoride Retention in the Mouth of Older Adults
- NCT number
- NCT04239872
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Hyposalivation
- Interventions
- Fluoride mouthwash, Calcium and fluoride mouthwash
- First posted
- 2020-01-27
- Last updated
- 2023-01-31
- Results first posted
- 2022-06-21
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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). |
| Primary | 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). |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fluoride Concentration in Dental Biofilm Fluid at Baseline | Baseline | 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. | parts per million (ppm) of fluoride | GEOMETRIC_MEAN |
| PRIMARY | Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes | 15 minutes after mouthwash(es) | 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. | parts per million (ppm) of fluoride | GEOMETRIC_MEAN |
| PRIMARY | Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes | 60 minutes after mouthwash(es) | 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. | parts per million (ppm) of fluoride | GEOMETRIC_MEAN |
| PRIMARY | Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes | 120 minutes after mouthwash(es) | 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. | parts per million (ppm) of fluoride | GEOMETRIC_MEAN |
| PRIMARY | Fluoride Concentration in Dental Biofilm Solids at Baseline | Baseline | 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. | micrograms fluoride/milligram protein | GEOMETRIC_MEAN |
| PRIMARY | Fluoride Concentration in Dental Biofilm Solids at 15 Minutes | 15 minutes after mouthwash(es) | 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. | micrograms fluoride/milligram protein | GEOMETRIC_MEAN |
| PRIMARY | Fluoride Concentration in Dental Biofilm Solids at 60 Minutes | 60 minutes after mouthwash(es) | 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. | micrograms fluoride/miligram protein | GEOMETRIC_MEAN |
| PRIMARY | Fluoride Concentration in Dental Biofilm Solids at 120 Minutes | 120 minutes after mouthwash(es) | 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. | micrograms fluoride/miligram protein | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid Overtime | Baseline, 15, 60 and 120 minutes after mouthwash(es) | 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. | parts per million x minutes | MEAN |
| PRIMARY | Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids Overtime | Baseline, 15, 60 and 120 minutes after mouthwash | 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. | microgram fluoride/milligram prot x min | GEOMETRIC_MEAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fluoride Concentration in Dental Biofilm Fluid at Baseline | Fluoride Mouthwash | 0.24 | 95% Confidence Interval 0.18 to 0.32 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Fluid at Baseline | Calcium Mouthwash Before Fluoride Mouthwash | 0.22 | 95% Confidence Interval 0.17 to 0.29 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes | Fluoride Mouthwash | 15.27 | 95% Confidence Interval 7.84 to 29.76 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Fluid at 15 Minutes | Calcium Mouthwash Before Fluoride Mouthwash | 12.29 | 95% Confidence Interval 9.46 to 15.98 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes | Fluoride Mouthwash | 1.57 | 95% Confidence Interval 0.79 to 3.11 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Fluid at 60 Minutes | Calcium Mouthwash Before Fluoride Mouthwash | 4.07 | 95% Confidence Interval 2.63 to 6.31 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes | Fluoride Mouthwash | 0.63 | 95% Confidence Interval 0.40 to 0.99 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Fluid at 120 Minutes | Calcium Mouthwash Before Fluoride Mouthwash | 2.58 | 95% Confidence Interval 1.33 to 5.00 | parts per million (ppm) of fluoride | |
| Fluoride Concentration in Dental Biofilm Solids at Baseline | Fluoride Mouthwash | 0.17 | 95% Confidence Interval 0.09 to 0.32 | micrograms fluoride/milligram protein | |
| Fluoride Concentration in Dental Biofilm Solids at Baseline | Calcium Mouthwash Before Fluoride Mouthwash | 0.13 | 95% Confidence Interval 0.07 to 0.24 | micrograms fluoride/milligram protein |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluoride Mouthwash Alone, Then Calcium Mouthwash Before a Fluoride Mouthwash | 11 | |
| Overall Study | STARTED | Calcium Mouthwash Before a Fluoride Mouthwash, Then Fluoride Mouthwash Alone | 9 | |
| Overall Study | COMPLETED | Fluoride Mouthwash Alone, Then Calcium Mouthwash Before a Fluoride Mouthwash | 11 | |
| Overall Study | COMPLETED | Calcium Mouthwash Before a Fluoride Mouthwash, Then Fluoride Mouthwash Alone | 8 | |
| Overall Study | NOT COMPLETED | Fluoride Mouthwash Alone, Then Calcium Mouthwash Before a Fluoride Mouthwash | 0 | |
| Overall Study | NOT COMPLETED | Calcium Mouthwash Before a Fluoride Mouthwash, Then Fluoride Mouthwash Alone | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluoride Mouthwash | 0 | 19 |
| Total, all-cause mortality | Calcium Mouthwash Before Fluoride Mouthwash | 0 | 20 |
| Total, other adverse events | Fluoride Mouthwash | 0 | 19 |
| Total, other adverse events | Calcium Mouthwash Before Fluoride Mouthwash | 0 | 20 |
| Total, serious adverse events | Fluoride Mouthwash | 0 | 19 |
| Total, serious adverse events | Calcium Mouthwash Before Fluoride Mouthwash | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38877716 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR002240 | Michigan Institute for Clinical and Health Research (MICHR) | MASHOUR, GEORGE ALEXANDER; LUMENG, JULIE C | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2017 to 2022 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fluoride Mouthwash vs Calcium Mouthwash Before Fluoride Mouthwash: deaths from any cause | Trial comparisons |
| Fluoride Mouthwash vs Calcium Mouthwash Before Fluoride Mouthwash: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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