Dental CariesPhase 2NCT02388178
To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study
A Phase 2 study testing Experimental toothpaste containing fluoride and amino acid (arginine) and Fluoride toothpaste containing fluoride as the anti-cavity ingredient in people with Dental Caries, run by Colgate Palmolive.
Trial summary
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Experimental toothpaste containing fluoride and amino acid (arginine) and Fluoride toothpaste containing fluoride as the anti-cavity ingredient
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 2015
- Phase
- Phase 2
- 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
Who may be able to join
- Male and/or female subjects 18 to 50 years inclusive
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
- Willing to wear retainer 24 hours per day
- No active, unrestored cavities
- Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
- Available throughout entire study
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- Willing to use only assigned products for oral hygiene throughout the duration of the study
- Must give written informed consent
- Must be in good general health
- No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Who cannot join
- Advanced periodontal disease
- Medical condition which requires premedication prior to dental visits/procedures
- Not enough teeth to secure the oral retainer
- Diseases of the soft or hard oral tissues
- Wear an Orthodontic appliances
- Impaired salivary function
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- Current use drugs that can affect salivary flow
- Use antibiotics one (1) month prior to or during this study
- Pregnant or breastfeeding
- Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
- Use tobacco products
- Allergic to common toothpaste ingredients
- Allergic to amino acids
- Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)
About this study
Official title: Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
- Conditions
- Dental Caries
- Being tested
- Control toothpaste containing no anti-cavity ingredients, Experimental toothpaste containing fluoride and amino acid (arginine), Fluoride toothpaste containing fluoride as the anti-cavity ingredient
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control toothpaste containing no anti-cavity ingredientsDrug
Also called Fluoride free toothpaste control
Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
Experimental toothpaste containing fluoride and amino acid (arginine)Drug
Also called Experimental toothpaste
Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
Fluoride toothpaste containing fluoride as the anti-cavity ingredientDrug
Also called Fluoride only toothpaste control
Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride free, silica based toothpaste | Placebo comparator | Control toothpaste containing no anti-cavity ingredients Receives: Drug: Control toothpaste containing no anti-cavity ingredients; Drug: Experimental toothpaste containing fluoride and amino acid (arginine); Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient |
| fluoride + amino acid in a silica toothpaste | Experimental | Experimental toothpaste containing fluoride and amino acid (arginine) Receives: Drug: Control toothpaste containing no anti-cavity ingredients; Drug: Experimental toothpaste containing fluoride and amino acid (arginine); Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient |
| 1450 ppm fluoride in a silica base toothpaste | Active comparator | Fluoride toothpaste containing fluoride as the anti-cavity ingredient Receives: Drug: Control toothpaste containing no anti-cavity ingredients; Drug: Experimental toothpaste containing fluoride and amino acid (arginine); Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mineral Change (delta Z)
Tooth samples of human enamel are placed in a retainer and worn by each study subject. Enamel block samples will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm) before being placed in the retainer. These baseline values will be compared with the post use delta mineral change (∆ Z).
Measured: Baseline
Mineral Change (delta Z)
Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of wearing the study retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm). These post use values will be compared to the Baseline values to give a delta mineral change (∆ Z).
Measured: 2 weeks (from Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Why it stopped: The study was stopped due to business reasons.
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 Colgate PalmoliveThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bennet Amaechi, PhD, DDS, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388178
- Sponsor's protocol ID
- ERO-2014-CAI-02-RPS
- Status last verified
- Sep 2022
- First submitted
- 4 Feb 2015
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.
- ClinicalTrials.gov ID
- NCT02388178
- Acronym / sponsor ID
- ERO-2014-CAI-02-RPS
- Conditions
- Dental Caries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 13 Mar 2015 (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.
This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride free, silica based toothpaste | Placebo comparator | Drug: Control toothpaste containing no anti-cavity ingredients, Drug: Experimental toothpaste containing fluoride and amino acid (arginine), Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredientControl toothpaste containing no anti-cavity ingredients |
| fluoride + amino acid in a silica toothpaste | Experimental | Drug: Control toothpaste containing no anti-cavity ingredients, Drug: Experimental toothpaste containing fluoride and amino acid (arginine), Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredientExperimental toothpaste containing fluoride and amino acid (arginine) |
| 1450 ppm fluoride in a silica base toothpaste | Active comparator | Drug: Control toothpaste containing no anti-cavity ingredients, Drug: Experimental toothpaste containing fluoride and amino acid (arginine), Drug: Fluoride toothpaste containing fluoride as the anti-cavity ingredientFluoride toothpaste containing fluoride as the anti-cavity ingredient |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and/or female subjects 18 to 50 years inclusive
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
- Willing to wear retainer 24 hours per day
- No active, unrestored cavities
- Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
Key exclusion criteria (14 listed)
- Advanced periodontal disease
- Medical condition which requires premedication prior to dental visits/procedures
- Not enough teeth to secure the oral retainer
- Diseases of the soft or hard oral tissues
- Wear an Orthodontic appliances
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 |
|---|---|---|
| Control toothpaste containing no anti-cavity ingredientsAlso: Fluoride free toothpaste controlBrush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water. | Drug | 1450 ppm fluoride in a silica base toothpaste, Fluoride free, silica based toothpaste, fluoride + amino acid in a silica toothpaste |
| Experimental toothpaste containing fluoride and amino acid (arginine)Also: Experimental toothpasteBrush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water. | Drug | 1450 ppm fluoride in a silica base toothpaste, Fluoride free, silica based toothpaste, fluoride + amino acid in a silica toothpaste |
| Fluoride toothpaste containing fluoride as the anti-cavity ingredientAlso: Fluoride only toothpaste controlBrush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water. | Drug | 1450 ppm fluoride in a silica base toothpaste, Fluoride free, silica based toothpaste, fluoride + amino acid in a silica toothpaste |
Primary outcome
Mineral Change (delta Z)
Time frame: Baseline
Tooth samples of human enamel are placed in a retainer and worn by each study subject. Enamel block samples will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm) before being placed in the retainer. These baseline values will be compared with the post use delta mineral change (∆ Z).
Mineral Change (delta Z)
Time frame: 2 weeks (from Baseline)
Tooth samples of human enamel are placed in a retainer and worn by each study subject. After 2 weeks of wearing the study retainer, samples from the retainer will be x-rayed and analyzed for mineral level (volume % of micrometer of lesions , vol% µm). These post use values will be compared to the Baseline values to give a delta mineral change (∆ Z).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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.
Bennet Amaechi, PhD, DDS principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental toothpaste containing fluoride and amino acid (arginine) and Fluoride toothpaste containing fluoride as the anti-cavity ingredient in people with Dental Caries, run by Colgate Palmolive.
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 10 inclusion and 14 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: withdrawn, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Mineral Change (delta Z) (time frame: Baseline). 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 27 Sep 2022.