ClinicalTrials.gov
ClinicalTrials.gov Menu

Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02999230
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
Colgate Palmolive Co.
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Caries Free 1.5% Arginine Other: Caries Free Placebo Sodium Fluoride Other: Caries Active 1.5% Arginine Other: Caries Active- Placebo Sodium Fluoride Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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.
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

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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.


Secondary Outcome Measures :
  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Twenty natural 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
  • Unwilling or unable to provide informed consent and follow plaque/saliva collection instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999230


Contacts
Contact: Renita Jenkins, CDA 352-273-6933 rjenkins@dental.ufl.edu
Contact: Janice Braddy, CCRC 353-273-6669 jbraddy@dental.ufl.edu

Locations
United States, Florida
University of Florida College of Dentistry Recruiting
Gainesville, Florida, United States, 32610
Contact: Renita J Jenkins       RJenkins@dental.ufl.edu   
Sponsors and Collaborators
University of Florida
National Institute of Dental and Craniofacial Research (NIDCR)
Colgate Palmolive Co.
Investigators
Principal Investigator: Marcelle Nascimento, DDS, MS PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02999230     History of Changes
Other Study ID Numbers: IRB201602471-N
R01DE025832-01 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Cavities

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents