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Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health

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ClinicalTrials.gov Identifier: NCT02999230
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE December 21, 2016
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE February 22, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02999230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 16, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Official Title  ICMJE Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Other: Caries Free 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.
    Other Name: 1.5% Arginine
  • Other: Caries Free Placebo 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.
    Other Name: Sodium Fluoride
  • Other: Caries Active 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.
    Other Name: 1.5% Arginine
  • Other: Caries Active- Placebo 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.
    Other Name: Sodium Fluoride
Study Arms  ICMJE
  • 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.
    Intervention: Other: Caries Free 1.5% Arginine
  • 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.
    Intervention: Other: Caries Free Placebo Sodium Fluoride
  • 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.
    Intervention: Other: Caries Active 1.5% Arginine
  • 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.
    Intervention: Other: Caries Active- Placebo Sodium Fluoride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
230
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2016)
260
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Renita Jenkins, CDA 352-273-6933 rjenkins@dental.ufl.edu
Contact: Janice Braddy, CCRC 353-273-6669 jbraddy@dental.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02999230
Other Study ID Numbers  ICMJE IRB201602471-N
R01DE025832-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Marcelle Nascimento, DDS, MS PhD University of Florida
PRS Account University of Florida
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP