Dental CariesPhase 1NCT00642252
Development and Validation of a Multi-Mineral Fluoride Mouthrinse
A Phase 1 study testing Fluoride in people with Dental Caries, run by Indiana Nanotech, LLC at 1 site in United States.
Trial summary
The primary goals of this project are to determine the anticaries benefits of a prototype multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the remineralization of enamel white-spots (non-cavitated lesions). Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2013
- 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 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To participate in this study, panelists will be required to meet the following criteria:
- Subjects must be 13 - 65 years of age;
- Subjects must read and sign the Informed Consent prior to initiation of study procedures. All subjects will receive a copy of the signed Informed Consent;
- Subjects must have a reasonable functional dentition, without a large number of missing teeth, and teeth #'s 22-27 present;
- Have normal salivary gland function (unstimulated whole salivary flow rate equal to or greater than 0.25 ml/min and paraffin stimulated whole salivary flow rate equal to or at least 1.0 ml/min);
- Subjects must be willing to participate in the study, be able to follow the study directions, be willing to return for all specified visits at their appointed time, and to use the product as per instructions;
- Subjects must be in good general health based on medical history and oral soft and hard tissue examination.
Who cannot join
- Criteria that will not permit participation in this study will be as follows:
- Any subject who is pregnant or lactating - based on oral interview only - as pregnancy may interfere with the outcome of the study;
- Any subject who has a systemic health condition such as diabetes that could affect the outcome of the study at the discretion of the examiner;
- Any subject who has an oral condition, such as excessive, untreated dental caries, periodontal disease, chronic dental neglect, or any oral pathology including xerostomia determined by oral examination and subject history that in the opinion of the dental examiner could affect the outcome of the study;
- Any subject who has full dentures, or full orthodontic appliances. No use of nightguards will be permitted during the study period;
- Any subject who uses oral care products (other than those permitted) during the treatment or wash-out periods;
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- Any subject with an immunological disorders such as HIV positive, AIDS, and systemic Lupus Erythematosis;
- Any subject concurrently participating in another clinical study;
- Any subject currently taking antibiotics or other medications, which in the opinion of the Investigator/Examiner might influence the study outcome;
- Any subject with a history of sensitivity to oral products or allergies to ingredients in the products;
- Any subject who fails to keep any of their scheduled appointments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Crispus Attucks Medical Magnet High School
Indianapolis, Indiana, 46202
About this study
The primary goals of this project are to determine the anticaries benefits of a prototype multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the remineralization of enamel white-spots (non-cavitated lesions). The selection of patients with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel white-spot lesions.
- Conditions
- Dental Caries
- Being tested
- Fluoride
- Keywords
- remineraliation, pre-existing white-spot (non-cavitated) enamel lesions
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideDrug
Also called ACT fluoride mouthrinse
Over-the-counter level of fluoride (226 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
FluorideDrug
Also called New mouthrinse
Over-the-counter level of fluoride (226 ppm) plus calcium (30 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | 226 ppm fluoride + 30 ppm calcium 'prototype/new' mouthrinse Receives: Drug: Fluoride |
| A | Active comparator | ADA-accepted over-the-counter 226 ppm fluoride mouthrinse (i.e. ACT, 226 ppm fluoride mouthrinse distributed by Chattem, Inc.) Receives: Drug: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization of non-cavitated enamel lesions.
Measured: baseline, 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Nanotech, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robert L. Karlinsey, Indiana Nanotech, LLC
- Investigators
- George K Stookey, PhD, Study director, Indiana Nanotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642252
- Sponsor's protocol ID
- Nanotech Phase II April 2008
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2008
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multi-Mineral Fluoride Mouthrinse
- ClinicalTrials.gov ID
- NCT00642252
- Acronym / sponsor ID
- Nanotech Phase II April 2008
- Conditions
- Dental Caries
- Keywords
- remineraliation, pre-existing white-spot (non-cavitated) enamel lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana Nanotech, LLCUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Mar 2008 (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.
The primary goals of this project are to determine the anticaries benefits of a prototype multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the remineralization of enamel white-spots (non-cavitated lesions). The selection of patients with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel white-spot lesions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: Fluoride226 ppm fluoride + 30 ppm calcium 'prototype/new' mouthrinse |
| A | Active comparator | Drug: FluorideADA-accepted over-the-counter 226 ppm fluoride mouthrinse (i.e. ACT, 226 ppm fluoride mouthrinse distributed by Chattem, Inc.) |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be 13 - 65 years of age;
- Subjects must read and sign the Informed Consent prior to initiation of study procedures. All subjects will receive a copy of the signed Informed Consent;
- Subjects must have a reasonable functional dentition, without a large number of missing teeth, and teeth #'s 22-27 present;
- Have normal salivary gland function (unstimulated whole salivary flow rate equal to or greater than 0.25 ml/min and paraffin stimulated whole salivary flow rate equal to or at least 1.0 ml/min);
- Subjects must be willing to participate in the study, be able to follow the study directions, be willing to return for all specified visits at their appointed time, and to use the product as per instructions;
Key exclusion criteria (11 listed)
- Any subject who is pregnant or lactating - based on oral interview only - as pregnancy may interfere with the outcome of the study;
- Any subject who has a systemic health condition such as diabetes that could affect the outcome of the study at the discretion of the examiner;
- Any subject who has an oral condition, such as excessive, untreated dental caries, periodontal disease, chronic dental neglect, or any oral pathology including xerostomia determined by oral examination and subject history that in the opinion of the dental examiner could affect the outcome of the study;
- Any subject who has full dentures, or full orthodontic appliances. No use of nightguards will be permitted during the study period;
- Any subject who uses oral care products (other than those permitted) during the treatment or wash-out periods;
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 |
|---|---|---|
| FluorideAlso: ACT fluoride mouthrinseOver-the-counter level of fluoride (226 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment. | Drug | A |
| FluorideAlso: New mouthrinseOver-the-counter level of fluoride (226 ppm) plus calcium (30 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment. | Drug | B |
Primary outcome
Remineralization of non-cavitated enamel lesions.
Time frame: baseline, 6, 12, 18, 24 months
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 Mar 2015.
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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.
George K Stookey, PhD study director
Indiana Nanotech
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 in people with Dental Caries, run by Indiana Nanotech, LLC 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 11 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 Mar 2015. 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?
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?
Remineralization of non-cavitated enamel lesions. (time frame: baseline, 6, 12, 18, 24 months). 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 Mar 2015.