Dental CariesPhase 2NCT02130206
The Microbiology of Caries Resistance
A Phase 2 study testing Caries Free and Caries Active in people with Dental Caries, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the bacterial composition of plaque and saliva located in the mouth and associate that with risk factors that cause cavities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Caries Free and Caries Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Nov 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Twenty natural teeth excluding third molars
- No contraindications to dental treatment
- Caries Free
- Caries Active (at least two active sites)
Who cannot join
- Less that twenty teeth
- Any systemic disease that can cause xerostomia
- Taking medications that cause xerostomia
- Antibiotics last three months
- Advanced Periodontal Disease
- Removable or fixed dental appliances
Show all 12Show fewer
- Bleeding disorders or taking anticoagulant medications
- Immune compromised individuals
- Participating in another research study
- Used flavored products such as mint flavored candies and chewing gum one week prior to or during the study
- Uses tobacco products
- Unwilling or unable to provide Informed Consent and follow collection instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Dentistry
Gainesville, Florida, 32610
About this study
Official title: The Microbiology of Caries Resistance. Subtitle: Functional Amyloid Formation in Streptococcus Mutans
The purpose of this research study is to investigate the bacterial composition of plaque and saliva located in the mouth and associate that with risk factors that cause cavities.
Read the detailed description
Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked to fill out a study registration form and an oral habits/medical history form. They will be asked to sign an Informed Consent. The subject will then have their teeth and gums examined. At this visit, the investigator will assess whether or not the subject is a good candidate for the study. During the phone interview each subject was asked not to brush or floss their teeth and not to eat or drink anything other than water for 8 hours prior to the pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline). If not, they will be asked to return to the clinic for another visit and asked not to brush or floss their teeth and not to eat or drink anything other than water 8 hours prior to that appointment. This visit will then be consider Visit 1 (Baseline).
Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They will have their teeth and gums examined. Saliva and plaque will be collected. Each subject will be given a toothbrush and toothpaste and instructed to not use any other dental products. This will be considered the "washout" period.
Visit 2 - The subject will be asked to return the unused toothpaste. Their medical and dental history will be reviewed and they will have their teeth examined. Saliva and plaque will be collected at this visit. The subjects will then be randomly assigned (by chance, like the flip of a coin) to the group that will use a marketed fluoride-containing toothpaste or to the group that will use a marketed arginine containing toothpaste. The subject will also be instructed not to brush or floss their teeth or eat or drink anything other than water for 8 hours prior to your next appointment.
Visits 3, 4, and 5 - Subjects will not be allowed to brush or floss their teeth or eat or drink anything other than water 8 hours prior to these visits. Saliva and plaque will be collected. On the 5th visit subjects will be asked to return the unused toothpaste tube. At this time participation in this research study will end and they will be instructed to return to their regular oral hygiene regiments.
- Conditions
- Dental Caries
- Being tested
- Caries Free, Caries Active, Caries Free - Placebo, Caries Active - Placebo
- Keywords
- Plaque, Saliva, Cavities
- Medical subject headings
- Dental Caries, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries FreeOther
Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
Caries ActiveOther
Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
Caries Free - PlaceboOther
Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
Caries Active - PlaceboOther
Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
| Study group | Role | What they receive |
|---|---|---|
| Caries Free | Active comparator | Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine. Receives: Other: Caries Free |
| Caries Free - Placebo | Placebo comparator | Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned. Receives: Other: Caries Free - Placebo |
| Caries Active | Active comparator | Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine. Receives: Other: Caries Active |
| Caries Active - Placebo | Placebo comparator | Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned. Receives: Other: Caries Active - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to month 2
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from baseline to month 2 (Screening)
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from month 2 to week 4
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from month 2 to week 4 (Baseline)
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 2
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from week 4 to week 2 (Washout)
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 8
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from week 2 to week 8 (Evaluation)
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Measured: Changes from week 8 to week 12 (Evaluation)
Secondary outcomes (5)
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to month 2
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from baseline to month 2 (Screening)
Bacteria collected from oral samples of healthy and caries-active subjects changes from month 2 to week 4
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from month 2 to week 4 (Baseline)
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 2
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from week 4 to week 2 (Washout)
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 8
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from week 2 to week 8 (Evaluation)
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Measured: Changes from week 8 to week 12 (Evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2014
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 University of FloridaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Marcelle Nascimento, DDS, MS, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130206
- Sponsor's protocol ID
- 665-2008
- Other IDs
- A-2013-197-OC
- Status last verified
- Nov 2016
- First submitted
- 25 Apr 2014
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbiology of Caries Resistance. Subtitle: Functional Amyloid Formation in Streptococcus Mutans
- ClinicalTrials.gov ID
- NCT02130206
- Acronym / sponsor ID
- 665-2008
- Conditions
- Dental Caries
- Keywords
- Plaque, Saliva, Cavities
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 May 2014 (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 research study is to investigate the bacterial composition of plaque and saliva located in the mouth and associate that with risk factors that cause cavities.
Detailed description
Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked to fill out a study registration form and an oral habits/medical history form. They will be asked to sign an Informed Consent. The subject will then have their teeth and gums examined. At this visit, the investigator will assess whether or not the subject is a good candidate for the study. During the phone interview each subject was asked not to brush or floss their teeth and not to eat or drink anything other than water for 8 hours prior to the pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline). If not, they will be asked to return to the clinic for another visit and asked not to brush or floss their teeth and not to eat or drink anything other than water 8 hours prior to that appointment. This visit will then be consider Visit 1 (Baseline).
Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They will have their teeth and gums examined. Saliva and plaque will be collected. Each subject will be given a toothbrush and toothpaste and instructed to not use any other dental products. This will be considered the "washout" period.
Visit 2 - The subject will be asked to return the unused toothpaste. Their medical and dental history will be reviewed and they will have their teeth examined. Saliva and plaque will be collected at this visit. The subjects will then be randomly assigned (by chance, like the flip of a coin) to the group that will use a marketed fluoride-containing toothpaste or to the group that will use a marketed arginine containing toothpaste. The subject will also be instructed not to brush or floss their teeth or eat or drink anything other than water for 8 hours prior to your next appointment.
Visits 3, 4, and 5 - Subjects will not be allowed to brush or floss their teeth or eat or drink anything other than water 8 hours prior to these visits. Saliva and plaque will be collected. On the 5th visit subjects will be asked to return the unused toothpaste tube. At this time participation in this research study will end and they will be instructed to return to their regular oral hygiene regiments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caries Free | Active comparator | Other: Caries FreeGums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine. |
| Caries Free - Placebo | Placebo comparator | Other: Caries Free - PlaceboGums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned. |
| Caries Active | Active comparator | Other: Caries ActiveGums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine. |
| Caries Active - Placebo | Placebo comparator | Other: Caries Active - PlaceboGums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Twenty natural teeth excluding third molars
- No contraindications to dental treatment
- Caries Free
- Caries Active (at least two active sites)
Key exclusion criteria (12 listed)
- Less that twenty teeth
- Any systemic disease that can cause xerostomia
- Taking medications that cause xerostomia
- Antibiotics last three months
- Advanced Periodontal Disease
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 |
|---|---|---|
| Caries FreeGums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine. | Other | Caries Free |
| Caries ActiveGums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine. | Other | Caries Active |
| Caries Free - PlaceboGums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned. | Other | Caries Free - Placebo |
| Caries Active - PlaceboGums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned. | Other | Caries Active - Placebo |
Primary outcome
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to month 2
Time frame: Changes from baseline to month 2 (Screening)
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from month 2 to week 4
Time frame: Changes from month 2 to week 4 (Baseline)
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 2
Time frame: Changes from week 4 to week 2 (Washout)
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 8
Time frame: Changes from week 2 to week 8 (Evaluation)
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12
Time frame: Changes from week 8 to week 12 (Evaluation)
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
5 secondary outcomes
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to month 2
Time frame: Changes from baseline to month 2 (Screening)
Bacteria collected from oral samples of healthy and caries-active subjects changes from month 2 to week 4
Time frame: Changes from month 2 to week 4 (Baseline)
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 2
Time frame: Changes from week 4 to week 2 (Washout)
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 8
Time frame: Changes from week 2 to week 8 (Evaluation)
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12
Time frame: Changes from week 8 to week 12 (Evaluation)
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 9 Nov 2016.
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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.
Marcelle Nascimento, DDS, MS, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caries Free and Caries Active in people with Dental Caries, run by University of Florida 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 4 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 9 Nov 2016. 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. 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 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?
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to month 2 (time frame: Changes from baseline to month 2 (Screening)). The study lists 5 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 9 Nov 2016.