Dental CariesNCT02999230
Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
A study testing Caries Free 1.5% Arginine and Caries Active 1.5% Arginine in people with Dental Caries, run by University of Florida at 1 site in United States.
Trial summary
This study will examine the mechanisms of action of probiotics and synbiotics for control of oral diseases, with a particular focus on exploring new strategies for caries prevention and treatment. 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 1.5% Arginine and Caries Active 1.5% Arginine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 25 Jun 2020
- Phase
- Interventional
- 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 uncrowned teeth excluding third molars
- No contraindications to dental treatment
- Caries Free-(with no clinical evidence of past or present caries)
- Caries Active- (At least two active sites)
Who cannot join
- Less than 20 teeth
- Systemic disease that can cause xerostomia
- Taking medication known to cause xerostomia
- Have been treated with antibiotics within the past 3 months
- Advanced periodontal disease
- Removable or fixed dental appliances
Show all 12Show fewer
- Bleeding disorders or taking anticoagulant medications
- Immune compromised individuals
- Uses tobacco products
- Participation in another clinical study one week prior to the start of the washout period or during the study period
- Use of any flavored products, such as mint flavored candies and chewing gum, one week prior to or during the study
- Unwilling or unable to provide informed consent and follow plaque/saliva 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
This study will examine the mechanisms of action of probiotics and synbiotics for control of oral diseases, with a particular focus on exploring new strategies for caries prevention and treatment.
Read the detailed description
Subjects recruited in years 1, 2, and 4 will only be seen for one study visit and will follow the research visit protocol listed below:
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. This will be the end of the study for subjects recruited in years 1, 2, and 4.
Subjects will be grouped by the year they participate in the study. Subjects recruited in year 3 will follow the research visit protocol outlined below:
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 considered 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 the 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 1.5% Arginine, Caries Free Placebo Sodium Fluoride, Caries Active 1.5% Arginine, Caries Active- Placebo Sodium Fluoride
- Keywords
- Cavities
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caries Free 1.5% ArginineOther
Also called 1.5% Arginine
Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
Caries Free Placebo Sodium FluorideOther
Also called Sodium Fluoride
Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
Caries Active 1.5% ArginineOther
Also called 1.5% Arginine
Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
Caries Active- Placebo Sodium FluorideOther
Also called Sodium Fluoride
Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Caries Free | Active comparator | Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned. Receives: Other: Caries Free 1.5% Arginine |
| Caries Free- Placebo | Placebo comparator | Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned. Receives: Other: Caries Free Placebo Sodium Fluoride |
| Caries Active | Active comparator | Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned. Receives: Other: Caries Active 1.5% Arginine |
| Caries Active- Placebo | Placebo comparator | Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned. Receives: Other: Caries Active- Placebo Sodium Fluoride |
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 week 2
Saliva and dental plaque will be collected during the baseline and week 2 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Measured: Changes from baseline to 2 weeks (Screening)
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4
Saliva and dental plaque will be collected during the week 2 and week 4 study visits. The amount of citrulline and/or ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Measured: Changes from week 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 8
Saliva and dental plaque will be collected during the week 4 and week 8 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Measured: Changes from week 4 to week 8 (Washout)
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 week 8 and week 12 visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols
Measured: Changes from week 8 to week 12 (Evaluation)
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.
Saliva and dental plaque will be collected during the baseline and week 12 study visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Measured: Changes from baseline to week 12 (Evaluation)
Secondary outcomes (5)
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2
Saliva and dental plaque will be collected during the baseline and week 2 study visits.Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
Measured: Changes from baseline to week 2
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4
Saliva and dental plaque will be collected during the week 2 and week 4 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
Measured: Changes from week 2 to week 4
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8
Saliva and dental plaque will be collected during the week 4 to week 8 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
Measured: Changes from week 4 to week 8
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 week 8 and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
Measured: Changes from week 8 to week 12
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12
Saliva and dental plaque will be collected during the baseline and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
Measured: Changes from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start22 Feb 2017
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Marcelle Nascimento, DDS, MS PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999230
- Sponsor's protocol ID
- IRB201602471-N
- Other IDs
- 5R01DE025832-05
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2016
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
- ClinicalTrials.gov ID
- NCT02999230
- Acronym / sponsor ID
- IRB201602471-N
- Conditions
- Dental Caries
- Keywords
- Cavities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 21 Dec 2016 (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 study will examine the mechanisms of action of probiotics and synbiotics for control of oral diseases, with a particular focus on exploring new strategies for caries prevention and treatment.
Detailed description
Subjects recruited in years 1, 2, and 4 will only be seen for one study visit and will follow the research visit protocol listed below:
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. This will be the end of the study for subjects recruited in years 1, 2, and 4.
Subjects will be grouped by the year they participate in the study. Subjects recruited in year 3 will follow the research visit protocol outlined below:
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 considered 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 the 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caries Free | Active comparator | Other: Caries Free 1.5% ArginineGums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned. |
| Caries Free- Placebo | Placebo comparator | Other: Caries Free Placebo Sodium FluorideGums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned. |
| Caries Active | Active comparator | Other: Caries Active 1.5% ArginineGums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned. |
| Caries Active- Placebo | Placebo comparator | Other: Caries Active- Placebo Sodium FluorideGums will be examined and caries assessment performed. On some visits Saliva and supragingival 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 uncrowned teeth excluding third molars
- No contraindications to dental treatment
- Caries Free-(with no clinical evidence of past or present caries)
- Caries Active- (At least two active sites)
Key exclusion criteria (12 listed)
- Less than 20 teeth
- Systemic disease that can cause xerostomia
- Taking medication known to cause xerostomia
- Have been treated with antibiotics within the past 3 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 Free 1.5% ArginineAlso: 1.5% ArginineStudy toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day. | Other | Caries Free |
| Caries Free Placebo Sodium FluorideAlso: Sodium FluorideMarketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day. | Other | Caries Free- Placebo |
| Caries Active 1.5% ArginineAlso: 1.5% ArginineStudy toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day. | Other | Caries Active |
| Caries Active- Placebo Sodium FluorideAlso: Sodium FluorideMarketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day. | 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 week 2
Time frame: Changes from baseline to 2 weeks (Screening)
Saliva and dental plaque will be collected during the baseline and week 2 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4
Time frame: Changes from week 2 to week 4 (Baseline)
Saliva and dental plaque will be collected during the week 2 and week 4 study visits. The amount of citrulline and/or ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8
Time frame: Changes from week 4 to week 8 (Washout)
Saliva and dental plaque will be collected during the week 4 and week 8 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
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 week 8 and week 12 visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.
Time frame: Changes from baseline to week 12 (Evaluation)
Saliva and dental plaque will be collected during the baseline and week 12 study visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
5 secondary outcomes
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2
Time frame: Changes from baseline to week 2
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4
Time frame: Changes from week 2 to week 4
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8
Time frame: Changes from week 4 to week 8
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
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12
Time frame: Changes from baseline to week 12
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 1 Oct 2024.
- Individual participant dataSharing planned: No
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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 study testing Caries Free 1.5% Arginine and Caries Active 1.5% Arginine 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 1 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. 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.
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 week 2 (time frame: Changes from baseline to 2 weeks (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 1 Oct 2024.