CariesNCT01650493
In-situ Evaluation of Anti-caries Technology
An observational study of Caries, run by Solventum US LLC at 1 site in United States.
Trial summary
Three toothpastes will be compared, two toothpastes in each subject, to establish whether changes in the depth or area of an artificially created area of tooth decay is the same for each toothpaste. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Clinpro 5000, MI Paste Plus and Tom's of Maine
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jul 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Generally healthy subjects in need of a full-coverage crown on a mandibular first or second molar
Who may be able to join
- generally good physical health
- at least 18 years old
- needs a full crown on a mandibular first or second molar tooth
- tooth brushing frequency of twice daily or more
- agrees not to participate in other clinical study for duration of this study
- agrees to delay any elective dentistry, including dental prophylaxis, until study complete
Who cannot join
- any condition requiring antibiotic premedication before a dental procedure
- active treatment for cancer or seizure disorder
- diseases or conditions that could interfere with subject safely completing the study
- currently taking antibiotics or anti-cholinergic medications
- currently using extensive daily fluoride therapy
- gross, visible caries
Show all 12Show fewer
- chronic use of chlorhexidine within 3 months of baseline
- use of systemic antibiotics within 7 days of baseline
- severe periodontal disease
- use of any fluoride rinses or gels one month prior to study initiation
- pregnancy, the intention to become pregnant
- presence of orthodontic bands or removable retainers
Trial locations and contacts
1 site in 1 country.
United States1 site
Dows Institute for Dental Research
Iowa City, Iowa, 52242
About this study
Three toothpastes will be compared, two toothpastes in each subject, to establish whether changes in the depth or area of an artificially created area of tooth decay is the same for each toothpaste.
Read the detailed description
Objective is to evaluate the demineralization and remineralization effects of two experimental fluoride containing dentrifices on enamel and root surface lesions compared with a control dentrifice.
Study is a partially randomized, 3-period cross over study involving 30 subjects who need a full-coverage crown on a posterior tooth. Each subject will use each of the study dentrifices over 3 months according to a randomization scheme. Subjects will brush daily with the assigned dentrifice unsupervised. Subjects will each have two provisonal crowns for use during the study. These crowns will contain three hard tooth tissue sections located at interproximal sites. The three tooth tissue slabs will consist of an artificial enamel caries lesion, an artificial root caries lesion, and a sound root. After removal, the tooth slabs will be evaluated using polarized light and photomicrographs for changes in area and depth of lesions.
- Conditions
- Caries
- Being tested
- Clinpro 5000, MI Paste Plus, Tom's of Maine
- Keywords
- remineralization, demineralzation, in situ, dentrifice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinpro 5000Device
Dentrifice containing 950ppm fluoride
MI Paste PlusDevice
Dentrifice containing 950ppm fluoride
Tom's of MaineDevice
Dentrifice that is fluoride free
| Study group | Role | What they receive |
|---|---|---|
| Group A | Clinpro 5000 Receives: Device: Clinpro 5000 | |
| Group B | MI Paste Plus Receives: Device: MI Paste Plus | |
| Group C | Toms of Maine Receives: Device: Tom's of Maine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depth of artificial lesion over 3 months
Comparison of two 950 ppm fluoride containing dentrifices, Clinpro Toothcreme and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine)for any change in artificial lesion depth due to demineralization or remineralization over the time period of the study
Measured: 3 months
Change in area of artificial lesion over 3 months
Comparison of two 950 ppm fluoride containing dentrifices, Clinpro 5000 and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine) for any change in artificial lesion area due to demineralization or remineralization over time period of study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Iowa, 3M
- Responsible party
- Sponsor
- Investigators
- Clark Stanford, PhD, Principal investigator, Dows Institute for Dental Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650493
- Sponsor's protocol ID
- CR-11-012
- Status last verified
- Sep 2024
- First submitted
- 14 Jun 2012
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-situ Evaluation of Anti-caries Technology
- ClinicalTrials.gov ID
- NCT01650493
- Acronym / sponsor ID
- CR-11-012
- Conditions
- Caries
- Keywords
- remineralization, demineralzation, in situ, dentrifice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Iowa, 3M
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jul 2012 (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.
Three toothpastes will be compared, two toothpastes in each subject, to establish whether changes in the depth or area of an artificially created area of tooth decay is the same for each toothpaste.
Detailed description
Objective is to evaluate the demineralization and remineralization effects of two experimental fluoride containing dentrifices on enamel and root surface lesions compared with a control dentrifice.
Study is a partially randomized, 3-period cross over study involving 30 subjects who need a full-coverage crown on a posterior tooth. Each subject will use each of the study dentrifices over 3 months according to a randomization scheme. Subjects will brush daily with the assigned dentrifice unsupervised. Subjects will each have two provisonal crowns for use during the study. These crowns will contain three hard tooth tissue sections located at interproximal sites. The three tooth tissue slabs will consist of an artificial enamel caries lesion, an artificial root caries lesion, and a sound root. After removal, the tooth slabs will be evaluated using polarized light and photomicrographs for changes in area and depth of lesions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Clinpro 5000Clinpro 5000 |
| Group B | – | Device: MI Paste PlusMI Paste Plus |
| Group C | – | Device: Tom's of MaineToms of Maine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Generally healthy subjects in need of a full-coverage crown on a mandibular first or second molar
Key inclusion criteria (6 listed)
- generally good physical health
- at least 18 years old
- needs a full crown on a mandibular first or second molar tooth
- tooth brushing frequency of twice daily or more
- agrees not to participate in other clinical study for duration of this study
Key exclusion criteria (12 listed)
- any condition requiring antibiotic premedication before a dental procedure
- active treatment for cancer or seizure disorder
- diseases or conditions that could interfere with subject safely completing the study
- currently taking antibiotics or anti-cholinergic medications
- currently using extensive daily fluoride therapy
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 |
|---|---|---|
| Clinpro 5000Dentrifice containing 950ppm fluoride | Device | Group A |
| MI Paste PlusDentrifice containing 950ppm fluoride | Device | Group B |
| Tom's of MaineDentrifice that is fluoride free | Device | Group C |
Primary outcome
Change in depth of artificial lesion over 3 months
Time frame: 3 months
Comparison of two 950 ppm fluoride containing dentrifices, Clinpro Toothcreme and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine)for any change in artificial lesion depth due to demineralization or remineralization over the time period of the study
Change in area of artificial lesion over 3 months
Time frame: 3 months
Comparison of two 950 ppm fluoride containing dentrifices, Clinpro 5000 and MI Paste Plus, with fluoride-free dentrifice (Toms of Maine) for any change in artificial lesion area due to demineralization or remineralization over time period of study
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 2 Oct 2024.
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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.
Clark Stanford, PhD principal investigator
Dows Institute for Dental Research
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 Caries, run by Solventum US 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 6 inclusion and 12 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 2 Oct 2024. 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?
Change in depth of artificial lesion over 3 months (time frame: 3 months). The study lists 2 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 2 Oct 2024.