Dental CariesPhase 1Fluor-CaNCT01473537
Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium
A Phase 1 study testing calcium lactate solution in people with Dental Caries, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse. Procedure: Rinses are performed in the evening. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- calcium lactate solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Sep 2012
- Phase
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- 10 natural teeth or more
- willing to refrain from use of fluoride containing products
- signed informed consent
Who cannot join
- less than 10 natural teeth
- reduced cognitive skills
- does not speak and/or understand Swedish
- ongoing oral or systemic infections
- pregnancy
- breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.
Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution.
Read more
Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration.
Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.
- Conditions
- Dental Caries
- Being tested
- calcium lactate solution
- Keywords
- dental caries/prevention and control, oral health, cariostatic agents
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium lactate solutionDrug
Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo
| Study group | Role | What they receive |
|---|---|---|
| calcium lactate solution 75 mM | Active comparator | Not described Receives: Drug: calcium lactate solution |
| calcium lactate solution 150 mM | Active comparator | Not described Receives: Drug: calcium lactate solution |
| placebo | Placebo comparator | Not described Receives: Drug: calcium lactate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoride concentration in resting saliva
Measured: 12 hours after rinse
Secondary outcomes (1)
Discomfort by calcium lactate rinse
Measured: 12 hours after rinse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionSep 2012
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 Karolinska InstitutetThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunilla Sandborgh Englund, Karolinska Institutet
- Investigators
- Gunilla Sandborgh-Englund, Prof, DDS, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473537
- Sponsor's protocol ID
- DDM 2011/1
- Other IDs
- 2011-001885-16
- Acronym
- Fluor-Ca
- Status last verified
- Sep 2012
- First submitted
- 14 Nov 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride
- ClinicalTrials.gov ID
- NCT01473537
- Acronym / sponsor ID
- Fluor-Ca / DDM 2011/1
- Conditions
- Dental Caries
- Keywords
- dental caries/prevention and control, oral health, cariostatic agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Nov 2011 (estimated)
- 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.
Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.
Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution.
Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration.
Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| calcium lactate solution 75 mM | Active comparator | Drug: calcium lactate solution |
| calcium lactate solution 150 mM | Active comparator | Drug: calcium lactate solution |
| placebo | Placebo comparator | Drug: calcium lactate solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- 10 natural teeth or more
- willing to refrain from use of fluoride containing products
- signed informed consent
Key exclusion criteria (6 listed)
- less than 10 natural teeth
- reduced cognitive skills
- does not speak and/or understand Swedish
- ongoing oral or systemic infections
- pregnancy
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 |
|---|---|---|
| calcium lactate solutionCalcium lactate solution 75 mM, 150 mM, 175 mM and placebo | Drug | calcium lactate solution 150 mM, calcium lactate solution 75 mM, placebo |
Primary outcome
Fluoride concentration in resting saliva
Time frame: 12 hours after rinse
1 secondary outcome
Discomfort by calcium lactate rinse
Time frame: 12 hours after rinse
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 25 Sep 2012.
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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.
Gunilla Sandborgh-Englund, Prof, DDS principal investigator
Karolinska Institutet
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 calcium lactate solution in people with Dental Caries, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 6 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 25 Sep 2012. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
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?
Fluoride concentration in resting saliva (time frame: 12 hours after rinse). 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 25 Sep 2012; AzTrials last refreshed its copy on 31 Oct 2026.