HyposalivationPhase 1NCT04239872
Fluoride Retention in the Mouth of Older Adults
A Phase 1 study testing Fluoride mouthwash and Calcium and fluoride mouthwash in people with Hyposalivation, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyposalivation
- What is being tested?
- Fluoride mouthwash and Calcium and fluoride mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 5 Apr 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Unable to understand and/or follow study instructions
- Active periodontitis
- Oral pain
- In need of urgent dental care
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dentistry, University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Optimizing Fluoride Retention in the Mouth of Older Adults With Distinct Salivary Flow Rates
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.
- Conditions
- Hyposalivation
- Being tested
- Fluoride mouthwash, Calcium and fluoride mouthwash
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride mouthwashDrug
Also called Fluoride rinse
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.
Calcium and fluoride mouthwashDrug
Also called Calcium and fluoride rinse
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fluoride mouthwash; Drug: Calcium and fluoride mouthwash |
| 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. Receives: Drug: Fluoride mouthwash; Drug: Calcium and fluoride mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline, 15, 60 and 120 minutes after mouthwash
Secondary outcomes (24)
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.
Measured: Baseline
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start11 Mar 2020
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyposalivationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Tenuta, University of Michigan
- Investigators
- Livia M Tenuta, DDS, MS, PhD, Principal investigator, Associate Professor, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239872
- Sponsor's protocol ID
- HUM00159624
- Other IDs
- UL1TR002240
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2020
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baez-Polan J, Danciu TE, Sweier D, Gonzalez-Cabezas C, Fontana M, Tenuta LMA. Enhancing Intraoral Fluoride Retention in Older Adults: A Randomized Crossover Study. JDR Clin Trans Res. 2025 Jan;10(1):16-23. doi: 10.1177/23800844241252816. Epub 2024 Jun 14.
PubMed 38877716
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Fluoride Retention in the Mouth of Older Adults With Distinct Salivary Flow Rates
- ClinicalTrials.gov ID
- NCT04239872
- Acronym / sponsor ID
- HUM00159624
- Conditions
- Hyposalivation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 21 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash | Experimental | Drug: Fluoride mouthwash, Drug: Calcium and fluoride mouthwashParticipants 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. |
| Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash alone | Experimental | Drug: Fluoride mouthwash, Drug: Calcium and fluoride mouthwashParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Unable to understand and/or follow study instructions
- Active periodontitis
- Oral pain
- In need of urgent dental care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride mouthwashAlso: Fluoride rinseSodium 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. | Drug | Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash alone, Fluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash |
| Calcium and fluoride mouthwashAlso: Calcium and fluoride rinseCalcium 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. | Drug | Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash alone, Fluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash |
Primary outcome
Fluoride Concentration in Dental Biofilm Fluid at Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
24 secondary outcomes
Fluoride Concentration in Saliva at Baseline
Time frame: Baseline
Fluoride Concentration in Saliva at 16 Minutes
Time frame: 16-21 minutes after mouthwash(es)
Fluoride Concentration in Saliva at 30 Minutes
Time frame: 30-35 minutes after mouthwash(es)
Fluoride Concentration in Saliva at 61 Minutes
Time frame: 61-66 minutes after mouthwash(es)
Fluoride Concentration in Saliva at 90 Minutes
Time frame: 90-95 minutes after mouthwash(es)
Fluoride Concentration in Saliva at 121 Minutes
Time frame: 121-126 minutes after mouthwash(es)
Calcium Concentration in Dental Biofilm Fluid at Baseline
Time frame: Baseline
Calcium Concentration in Dental Biofilm Fluid at 15 Minutes
Time frame: 15 minutes after mouthwash(es)
Calcium Concentration in Dental Biofilm Fluid at 60 Minutes
Time frame: 60 minutes after mouthwash(es)
Calcium Concentration in Dental Biofilm Fluid at 120 Minutes
Time frame: 120 minutes after mouthwash(es)
Calcium Concentration in Dental Biofilm Solids at Baseline
Time frame: Baseline
Calcium Concentration in Dental Biofilm Solids at 15 Minutes
Time frame: 15 minutes after mouthwash(es)
Calcium Concentration in Dental Biofilm Solids at 60 Minutes
Time frame: 60 minutes after mouthwash(es)
Calcium Concentration in Dental Biofilm Solids at 120 Minutes
Time frame: 120 minutes after mouthwash(es)
Calcium Concentration in Saliva at Baseline
Time frame: Baseline
Calcium Concentration in Saliva at 16 Minutes
Time frame: 16-21 minutes after mouthwash(es)
Calcium Concentration in Saliva at 30 Minutes
Time frame: 30-35 minutes after mouthwash(es)
Calcium Concentration in Saliva at 61 Minutes
Time frame: 61-66 minutes after mouthwash(es)
Calcium Concentration in Saliva at 90 Minutes
Time frame: 90-95 minutes after mouthwash(es)
Calcium Concentration in Saliva at 121 Minutes
Time frame: 121-126 minutes after mouthwash(es)
Area Under the Curve of Fluoride Concentration in Saliva Overtime
Time frame: Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es)
Area Under the Curve of Calcium Concentration in Dental Biofilm Fluid Overtime
Time frame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime
Time frame: Baseline, 15, 60 and 120 minutes after mouthwash(es)
Area Under the Curve of Calcium Concentration in Saliva Overtime
Time frame: Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38877716Baez-Polan J, Danciu TE, Sweier D, Gonzalez-Cabezas C, Fontana M, Tenuta LMA. Enhancing Intraoral Fluoride Retention in Older Adults: A Randomized Crossover Study. JDR Clin Trans Res. 2025 Jan;10(1):16-23. doi: 10.1177/23800844241252816. Epub 2024 Jun 14.
- Individual participant dataSharing planned: No
Related trials for Hyposalivation
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livia M Tenuta, DDS, MS, PhD principal investigator
Associate Professor, University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluoride mouthwash and Calcium and fluoride mouthwash in people with Hyposalivation, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluoride Concentration in Dental Biofilm Fluid at Baseline (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.