Tooth AbnormalityNCT01094210
Evaluation of a Low-fluoride Anticaries Toothpaste
An observational study of Tooth Abnormality, run by Indiana Nanotech, LLC at 1 site in United States.
Trial summary
The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Abnormality
- What is being tested?
- Fluorides, Topical
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Mar 2011
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This in situ study will recruit 30 adult subjects (between 18-50 years of age). No potential subject will be excluded from this study, regardless of their gender or racial/ethnic origins. However, it is expected that about 18 (60%) of the 30 subjects in the trial will be women. This distribution will allow for meaningful comparisons between gender groups. We will recruit patients attending the clinics of UTHSCSA dental school clinics, which reflect the ethnic mix of the area the clinics serve. However, majority of subjects will be Hispanic due to the high Hispanic prevalence (57.8%) in San Antonio. Thus, minorities will be included at a similar rate to that in the general population attending for dental care,
Who may be able to join
- 30 adult subjects (between 18-50 years of age)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dental Diagnostic Clinic within the University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology
The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.
- Conditions
- Tooth Abnormality
- Being tested
- Fluorides, Topical
- Keywords
- Anti-erosion dental benefits
- Medical subject headings
- Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorides, TopicalDrug
500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.
| Study group | Role | What they receive |
|---|---|---|
| G1 | 500 ppm F Test Toothpaste Receives: Drug: Fluorides, Topical | |
| G2 | 1100 ppm F Control Toothpaste Receives: Drug: Fluorides, Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Microhardness
Strength measurements made at the enamel surface of the enamel specimen
Measured: 30 days
Transverse Microradiography
X-ray analysis of enamel lesion
Measured: 30 days
Cross-Sectional Microhardness
Strength measurements made within the enamel lesion of the enamel specimen
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth AbnormalityStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Nanotech, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Responsible party
- Principal investigator, Dr. Robert L. Karlinsey, Indiana Nanotech, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094210
- Sponsor's protocol ID
- 1R43DE020998-01
- Status last verified
- Jun 2011
- First submitted
- 25 Mar 2010
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology
- ClinicalTrials.gov ID
- NCT01094210
- Acronym / sponsor ID
- 1R43DE020998-01
- Conditions
- Tooth Abnormality
- Keywords
- Anti-erosion dental benefits
- Study type
- Observational
- 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
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Mar 2010 (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 purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 | – | Drug: Fluorides, Topical500 ppm F Test Toothpaste |
| G2 | – | Drug: Fluorides, Topical1100 ppm F Control Toothpaste |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This in situ study will recruit 30 adult subjects (between 18-50 years of age). No potential subject will be excluded from this study, regardless of their gender or racial/ethnic origins. However, it is expected that about 18 (60%) of the 30 subjects in the trial will be women. This distribution will allow for meaningful comparisons between gender groups. We will recruit patients attending the clinics of UTHSCSA dental school clinics, which reflect the ethnic mix of the area the clinics serve. However, majority of subjects will be Hispanic due to the high Hispanic prevalence (57.8%) in San Antonio. Thus, minorities will be included at a similar rate to that in the general population attending for dental care,
Key inclusion criteria (1 listed)
- 30 adult subjects (between 18-50 years of age)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Fluorides, Topical500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each. | Drug | G1, G2 |
Primary outcome
Surface Microhardness
Time frame: 30 days
Strength measurements made at the enamel surface of the enamel specimen
Transverse Microradiography
Time frame: 30 days
X-ray analysis of enamel lesion
Cross-Sectional Microhardness
Time frame: 30 days
Strength measurements made within the enamel lesion of the enamel specimen
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Abnormality, 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 1 inclusion and 0 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.
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?
Surface Microhardness (time frame: 30 days). The study lists 3 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 25 Mar 2015.