- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02999230
Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida College of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Caries Free
Gums will be examined and caries assessment performed.
On some visits Saliva and supragingival plaque will be collected.
Study toothpaste will be assigned.
|
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.
Other Names:
|
Placebo Comparator: Caries Free- Placebo
Gums will be examined and caries assessment performed.
On some visits Saliva and supragingival plaque will be collected.
Marketed Toothpaste will be assigned.
|
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.
Other Names:
|
Active Comparator: Caries Active
Gums will be examined and caries assessment performed.
On some visits Saliva and plaque will be collected.
Study toothpaste will be assigned.
|
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.
Other Names:
|
Placebo Comparator: Caries Active- Placebo
Gums will be examined and caries assessment performed.
On some visits Saliva and supragingival plaque will be collected.
Marketed Toothpaste will be assigned.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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
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
|
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.
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.
|
Changes from baseline to week 12 (Evaluation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Changes from baseline to week 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary factors present in healthy and caries-active subjects during the research study.
Time Frame: Up to 6 months
|
Saliva will be collected from healthy and caries-active subjects during the research study.
The differences in salivary factors between the healthy and caries-active groups will be compared.
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcelle Nascimento, DDS, MS PhD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201602471-N
- 5R01DE025832-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Caries
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
3MUniversity of MichiganActive, not recruiting
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
Clinical Trials on Caries Free 1.5% Arginine
-
University of FloridaColgate PalmoliveCompleted
-
Trakya UniversityCommission of Scientific Research Projects of Trakya University (TÜBAP)CompletedEarly Childhood CariesTurkey
-
Colgate PalmoliveActive, not recruiting
-
Goldman, Butterwick, Fitzpatrick and GroffNot yet recruitingEpidermoid Cyst
-
Colgate PalmoliveCompleted
-
University of Electronic Science and Technology...Completed
-
Centro Cardiologico MonzinoMinistry of Health, ItalyRecruitingCardiac ArrhythmiaItaly
-
Tufts UniversityNational Pecan Shellers AssociationCompletedCardiovascular Disease Risk | Type 2 Diabetes RiskUnited States
-
Colgate PalmoliveCompletedHypersensitivityUnited States
-
University of Turin, ItalyTerminatedHypertension | Type 2 Diabetes MellitusItaly