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Completed

NCT Number: NCT04239872

Fluoride Retention in the Mouth of Older Adults

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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Key information

Conditions

Hyposalivation Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

School of Dentistry, University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Good general health as evidenced by medical history
  • Good oral health as evidenced by a clinical oral exam
  • Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
  • Having salivary flow rate ranging from normal to hyposalivation according to direct flow rate determination methods
  • Agreement to adhere to the study protocol

Exclusion criteria

  • Unable to understand and/or follow study instructions
  • Active periodontitis
  • Oral pain
  • In need of urgent dental care

Treatment and study plan

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.

Other names: Fluoride rinse

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.

Other names: Calcium and fluoride rinse

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

Secondary outcomes

  1. Fluoride Concentration in Saliva at Baseline

    Time frame: 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.

  2. Fluoride Concentration in Saliva at 16 Minutes

    Time frame: 16-21 minutes after mouthwash(es)

    Unstimulated saliva was collected 16 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.

  3. Fluoride Concentration in Saliva at 30 Minutes

    Time frame: 30-35 minutes after mouthwash(es)

    Unstimulated saliva was collected 30 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.

  4. Fluoride Concentration in Saliva at 61 Minutes

    Time frame: 61-66 minutes after mouthwash(es)

    Unstimulated saliva was collected 61 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.

  5. Fluoride Concentration in Saliva at 90 Minutes

    Time frame: 90-95 minutes after mouthwash(es)

    Unstimulated saliva was collected 90 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.

  6. Fluoride Concentration in Saliva at 121 Minutes

    Time frame: 121-126 minutes after mouthwash(es)

    Unstimulated saliva was collected 121 minutes after mouthwash(es), for 5 minutes. Fluoride concentration in unstimulated saliva was measured using an ion-specific electrode adapted for microanalysis.

  7. Calcium Concentration in Dental Biofilm Fluid at Baseline

    Time frame: 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.

  8. Calcium Concentration in Dental Biofilm Fluid at 15 Minutes

    Time frame: 15 minutes after mouthwash(es)

    Dental biofilm will be collected 15 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar.

  9. Calcium Concentration in Dental Biofilm Fluid at 60 Minutes

    Time frame: 60 minutes after mouthwash(es)

    Dental biofilm will be collected 60 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar.

  10. Calcium Concentration in Dental Biofilm Fluid at 120 Minutes

    Time frame: 120 minutes after mouthwash(es)

    Dental biofilm will be collected 120 minutes after mouthwash(es), and the fluid phase will be separated using centrifugation. Calcium concentration in the dental biofilm fluid will be measured using an ion-specific electrode adapted for microanalysis, and will be expressed in millimolar.

  11. Calcium 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 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.

  12. Calcium 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 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.

  13. Calcium Concentration in Dental Biofilm Solids at 60 Minutes

    Time frame: 60 minutes after mouthwash(es)

    Dental biofilm was collected 60 minutes after mouthwash(es). The fluid phase of the biofilm was collected after centrifugation, and the remaining solids were treated with strong acid for dissolution of calcium reservoirs. Solids remaining after acid extraction were treated with strong alkali for total dissolution of the biofilm and estimation of biofilm mass by protein concentration. Calcium concentration in the dental biofilm solids acid extract was measured using a colorimetric reaction (Arsenazo III); protein concentration in the alkali extract was determined using the Lowry colorimetric method. Calcium concentration in the biofilm was expressed as micrograms of calcium/milligrams of protein.

  14. Calcium 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 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. Calcium Concentration in Saliva at Baseline

    Time frame: 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).

  16. Calcium Concentration in Saliva at 16 Minutes

    Time frame: 16-21 minutes after mouthwash(es)

    Unstimulated saliva was collected at 16 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).

  17. Calcium Concentration in Saliva at 30 Minutes

    Time frame: 30-35 minutes after mouthwash(es)

    Unstimulated saliva was collected at 30 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).

  18. Calcium Concentration in Saliva at 61 Minutes

    Time frame: 61-66 minutes after mouthwash(es)

    Unstimulated saliva was collected at 61 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).

  19. Calcium Concentration in Saliva at 90 Minutes

    Time frame: 90-95 minutes after mouthwash(es)

    Unstimulated saliva was collected at 90 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).

  20. Calcium Concentration in Saliva at 121 Minutes

    Time frame: 121-126 minutes after mouthwash(es)

    Unstimulated saliva was collected at 121 minutes after mouthwash(es), for 5 minutes. Calcium concentration in unstimulated saliva was measured using a colorimetric reaction (Arsenazo III).

  21. Area Under the Curve of Fluoride Concentration in Saliva Overtime

    Time frame: Baseline, 16, 30, 61, 90 and 121 minutes after mouthwash(es)

    Fluoride concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of fluoride concentration in saliva as a function of time.

  22. Area Under the Curve of Calcium Concentration in Dental Biofilm Fluid Overtime

    Time frame: Baseline, 15, 60 and 120 minutes after mouthwash(es)

    Calcium concentration in dental biofilm fluid collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) will be expressed as the area under the curve of calcium concentration in dental biofilm fluid as a function of time (millimolar x min).

  23. Area Under the Curve of Calcium Concentration in Dental Biofilm Solids Overtime

    Time frame: Baseline, 15, 60 and 120 minutes after mouthwash(es)

    Calcium concentration in dental biofilm solids collected at baseline (before mouthwash(es)), 15, 60 and 120 minutes after mouthwash(es) was expressed as the area under the curve of calcium concentration in dental biofilm solids as a function of time.

  24. Area Under the Curve of Calcium Concentration in Saliva Overtime

    Time frame: Baseline, 16, 30, 61, 90 and 121 minutes after a mouthwash(es)

    Calcium concentration in unstimulated saliva collected at baseline (before mouthwash(es)), 16, 30, 61, 90 and 121 minutes after mouthwash(es) was expressed as the area under the curve of calcium concentration in saliva as a function of time (millimolar x min).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Optimizing Fluoride Retention in the Mouth of Older Adults With Distinct Salivary Flow Rates

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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