Dental CariesEarly Phase 1NCT04620252
Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride
A Early Phase 1 study testing Inactive supplement, Tricalcium phosphate supplement and Calcium carbonate supplement in people with Dental Caries, run by University of Michigan at 1 site in United States.
Trial summary
The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Inactive supplement, Tricalcium phosphate supplement and Calcium carbonate supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Mar 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, 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
- Reported good general health
- Reported good oral health
- Having at least 20 teeth in the mouth, being at least 4 (natural or crowned) teeth in all four quadrants of the mouth
- Having normal salivary flow rate 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
- Hyposalivation
- Active periodontitis, identified by frequent bleeding of the gums
- 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, 48109-1078
About this study
Official title: Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse
The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. Secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.
- Conditions
- Dental Caries
- Being tested
- Inactive supplement, Tricalcium phosphate supplement, Calcium carbonate supplement, Calcium citrate supplement, Inactive supplement and fluoride mouthwash
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactive supplementDrug
Chewable candy (negative control), chewed for 30 seconds.
Tricalcium phosphate supplementDrug
Chewable tricalcium phosphate supplement, chewed for 30 seconds.
Calcium carbonate supplementDrug
Chewable calcium carbonate supplement, chewed for 30 seconds.
Calcium citrate supplementDrug
Chewable calcium citrate supplement, chewed for 30 seconds.
Inactive supplement and fluoride mouthwashDrug
A chewable candy chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
Calcium carbonate supplement and fluoride mouthwashDrug
A calcium carbonate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
Calcium citrate supplement and fluoride mouthwashDrug
A calcium citrate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
| Study group | Role | What they receive |
|---|---|---|
| Chewing calcium supplements | Experimental | Participants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions.
Participants were randomized to determine the sequence of exposure to the different treatments. Receives: Drug: Inactive supplement; Drug: Tricalcium phosphate supplement; Drug: Calcium carbonate supplement; Drug: Calcium citrate supplement |
| Fluoride rinse | Experimental | Participants rinsed with an over the counter sodium fluoride rinse for 1 min, after having chewed a candy (negative control), a calcium calcium carbonate or a calcium citrate supplement. Receives: Drug: Inactive supplement and fluoride mouthwash; Drug: Calcium carbonate supplement and fluoride mouthwash; Drug: Calcium citrate supplement and fluoride mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium concentration in saliva at baseline
Saliva collected as one spit, immediately before chewing one of the calcium supplements to be tested in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: Baseline
Calcium concentration in the mixture of saliva and chewed calcium supplement
Saliva and remnants of the chewed calcium supplement collected at the end of the chewing period (30 seconds) in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: Immediately after the 30-second chewing of calcium supplement
Calcium concentration in saliva at 15 seconds
Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 15 seconds after chewing calcium supplement
Calcium concentration in saliva at 30 seconds
Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 30 seconds after chewing calcium supplement
Calcium concentration in saliva at 45 seconds
Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 45 seconds after chewing calcium supplement
Calcium concentration in saliva at 60 seconds
Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 60 seconds after chewing calcium supplement
Calcium concentration in saliva at 120 seconds
Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 120 seconds after chewing calcium supplement
Calcium concentration in saliva at 180 seconds
Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 180 seconds after chewing calcium supplement
Calcium concentration in saliva at 240 seconds
Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 240 seconds after chewing calcium supplement
Calcium concentration in saliva at 300 seconds
Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Measured: 300 seconds after chewing calcium supplement
Area under the curve of calcium concentration in saliva
Calcium concentration in saliva collected at baseline (before chewing the supplements), and 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing the supplements in Arm 1 expressed as the area under the curve of calcium concentration in saliva as a function of time (milimolar x min).
Measured: Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements
Fluoride concentration in saliva at baseline
Saliva will be collected for 2 min, immediately before chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.
Measured: Baseline
Fluoride concentration in saliva at time 0
Saliva and remnants of the fluoride mouth rinse collected at the end of the rinsing period (1 minute) in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Measured: 0 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 5 min
Saliva will be collected for 2 min, 5 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.
Measured: 5 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 15 min
Saliva collected for 2 min, 15 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Measured: 15 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 30 min
Saliva collected for 2 min, 30 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Measured: 30 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 60 min
Saliva collected for 2 min, 60 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Measured: 60 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva at 120 min
Saliva collected for 2 min, 120 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Measured: 120 minutes after chewing supplement/mouthwashing
Area under the curve of fluoride concentration in saliva
Fluoride concentration in saliva collected at baseline (before treatments), and 0, 5, 15, 30, 60 and 120 minutes after chewing the supplements and/or rinsing the fluoride mouthrinse in Arm 2 expressed as the area under the curve of fluoride concentration in saliva as a function of time (micromolar x min).
Measured: Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Feb 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 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
- NCT04620252
- Sponsor's protocol ID
- HUM00176242
- Status last verified
- May 2022
- First submitted
- 5 Nov 2020
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Fluoride Retention in the Mouth by Chewing a Calcium Supplement Before Fluoride Rinse
- ClinicalTrials.gov ID
- NCT04620252
- Acronym / sponsor ID
- HUM00176242
- Conditions
- Dental Caries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. Secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing calcium supplements | Experimental | Drug: Inactive supplement, Drug: Tricalcium phosphate supplement, Drug: Calcium carbonate supplement, Drug: Calcium citrate supplementParticipants were given one of 4 different treatments to chew: a negative control group and 3 calcium supplements with different calcium compositions. Participants were randomized to determine the sequence of exposure to the different treatments. |
| Fluoride rinse | Experimental | Drug: Inactive supplement and fluoride mouthwash, Drug: Calcium carbonate supplement and fluoride mouthwash, Drug: Calcium citrate supplement and fluoride mouthwashParticipants rinsed with an over the counter sodium fluoride rinse for 1 min, after having chewed a candy (negative control), a calcium calcium carbonate or a calcium citrate supplement. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, 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
- Reported good general health
- Reported good oral health
- 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 (5 listed)
- Unable to understand and/or follow study instructions
- Hyposalivation
- Active periodontitis, identified by frequent bleeding of the gums
- 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 |
|---|---|---|
| Inactive supplementChewable candy (negative control), chewed for 30 seconds. | Drug | Chewing calcium supplements |
| Tricalcium phosphate supplementChewable tricalcium phosphate supplement, chewed for 30 seconds. | Drug | Chewing calcium supplements |
| Calcium carbonate supplementChewable calcium carbonate supplement, chewed for 30 seconds. | Drug | Chewing calcium supplements |
| Calcium citrate supplementChewable calcium citrate supplement, chewed for 30 seconds. | Drug | Chewing calcium supplements |
| Inactive supplement and fluoride mouthwashA chewable candy chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride). | Drug | Fluoride rinse |
| Calcium carbonate supplement and fluoride mouthwashA calcium carbonate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride). | Drug | Fluoride rinse |
| Calcium citrate supplement and fluoride mouthwashA calcium citrate supplement chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride). | Drug | Fluoride rinse |
Primary outcome
Calcium concentration in saliva at baseline
Time frame: Baseline
Saliva collected as one spit, immediately before chewing one of the calcium supplements to be tested in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in the mixture of saliva and chewed calcium supplement
Time frame: Immediately after the 30-second chewing of calcium supplement
Saliva and remnants of the chewed calcium supplement collected at the end of the chewing period (30 seconds) in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 15 seconds
Time frame: 15 seconds after chewing calcium supplement
Saliva collected as one spit, 15 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 30 seconds
Time frame: 30 seconds after chewing calcium supplement
Saliva collected as one spit, 30 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 45 seconds
Time frame: 45 seconds after chewing calcium supplement
Saliva collected as one spit, 45 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 60 seconds
Time frame: 60 seconds after chewing calcium supplement
Saliva collected as one spit, 60 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 120 seconds
Time frame: 120 seconds after chewing calcium supplement
Saliva collected as one spit, 120 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 180 seconds
Time frame: 180 seconds after chewing calcium supplement
Saliva collected as one spit, 180 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 240 seconds
Time frame: 240 seconds after chewing calcium supplement
Saliva collected as one spit, 240 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Calcium concentration in saliva at 300 seconds
Time frame: 300 seconds after chewing calcium supplement
Saliva collected as one spit, 300 seconds after chewing the calcium supplement in Arm 1. Calcium concentration determined using a colorimetric method.
Area under the curve of calcium concentration in saliva
Time frame: Baseline, 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing calcium supplements
Calcium concentration in saliva collected at baseline (before chewing the supplements), and 15, 30, 45, 60, 120, 180, 240 and 300 seconds after chewing the supplements in Arm 1 expressed as the area under the curve of calcium concentration in saliva as a function of time (milimolar x min).
Fluoride concentration in saliva at baseline
Time frame: Baseline
Saliva will be collected for 2 min, immediately before chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.
Fluoride concentration in saliva at time 0
Time frame: 0 minutes after chewing supplement/mouthwashing
Saliva and remnants of the fluoride mouth rinse collected at the end of the rinsing period (1 minute) in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Fluoride concentration in saliva at 5 min
Time frame: 5 minutes after chewing supplement/mouthwashing
Saliva will be collected for 2 min, 5 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration will be determined using an ion-specific electrode.
Fluoride concentration in saliva at 15 min
Time frame: 15 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 15 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Fluoride concentration in saliva at 30 min
Time frame: 30 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 30 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Fluoride concentration in saliva at 60 min
Time frame: 60 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 60 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Fluoride concentration in saliva at 120 min
Time frame: 120 minutes after chewing supplement/mouthwashing
Saliva collected for 2 min, 120 min after chewing a calcium supplement and/or rinse with the fluoride mouthrinse in Arm 2. Fluoride concentration determined using an ion-specific electrode.
Area under the curve of fluoride concentration in saliva
Time frame: Baseline, 5, 15, 30, 60 and 120 minutes after chewing supplement/mouthwashing
Fluoride concentration in saliva collected at baseline (before treatments), and 0, 5, 15, 30, 60 and 120 minutes after chewing the supplements and/or rinsing the fluoride mouthrinse in Arm 2 expressed as the area under the curve of fluoride concentration in saliva as a function of time (micromolar x min).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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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 Early Phase 1 study testing Inactive supplement, Tricalcium phosphate supplement and Calcium carbonate supplement in people with Dental Caries, 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 5 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 9 May 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Calcium concentration in saliva at baseline (time frame: Baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2022.