NCT04239872

Brief Summary

Individuals with dry mouth (a reduction in the production of saliva) suffer from high rates of oral diseases. Dry mouth is a common problem among older individuals, because many medications to control chronic conditions (such as blood pressure, bladder-control problems and depression) reduce the flow of saliva. For these individuals, fluoride is used to maintain a good oral health. Usually, higher fluoride concentration products, such as prescription toothpastes, are recommended. In this project, the ability to increase fluoride retention in the mouth by using calcium before a conventional fluoride rinse will be tested in older adults with a range of salivary flow rates. This approach was never tested in patients with dry mouth, for whom the treatment with calcium may also be beneficial. A crossover, clinical study with two experimental phases will be conducted, in which patients with a range of saliva flows (from normal to dry mouth) will rinse with a fluoride rinse only (used at over the counter concentration), or a fluoride rinse preceded by a calcium rinse. The concentration of fluoride and calcium in the saliva and dental plaque residues will be determined up to two hours after the rinse(s), to test the effect of the approach to optimize fluoride retention in the mouth of patients with dry mouth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 21, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

January 15, 2020

Results QC Date

March 9, 2022

Last Update Submit

January 9, 2023

Conditions

Hyposalivation

Outcome Measures

Primary Outcomes (10)

  • 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.

    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

Secondary Outcomes (24)

  • Fluoride Concentration in Saliva at Baseline

    Baseline

  • Fluoride Concentration in Saliva at 16 Minutes

    16-21 minutes after mouthwash(es)

  • Fluoride Concentration in Saliva at 30 Minutes

    30-35 minutes after mouthwash(es)

  • Fluoride Concentration in Saliva at 61 Minutes

    61-66 minutes after mouthwash(es)

  • Fluoride Concentration in Saliva at 90 Minutes

    90-95 minutes after mouthwash(es)

  • +19 more secondary outcomes

Study Arms (2)

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.

Drug: Fluoride mouthwashDrug: 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.

Drug: Fluoride mouthwashDrug: Calcium and fluoride mouthwash

Interventions

Fluoride mouthwashDRUG

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.

Also known as: Fluoride rinse
Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash aloneFluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash
Calcium and fluoride mouthwashDRUG

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.

Also known as: Calcium and fluoride rinse
Calcium mouthwash before a fluoride mouthwash, then Fluoride mouthwash aloneFluoride mouthwash alone, then Calcium mouthwash before a fluoride mouthwash

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Calcium

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

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.

Results Point of Contact

Title
Dr. Livia Tenuta
Organization
University of Michigan School of Dentistry
litenuta@umich.edu
734-763-3703

Study Officials

  • Livia M Tenuta, DDS, MS, PhD

    Associate Professor, University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MS, PhD, Associate Professor

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 27, 2020

Study Start

March 11, 2020

Primary Completion

April 5, 2021

Study Completion

April 5, 2021

Last Updated

January 31, 2023

Results First Posted

June 21, 2022

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)