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Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health

Primary Purpose

Dental Caries

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caries Free 1.5% Arginine
Caries Free Placebo Sodium Fluoride
Caries Active 1.5% Arginine
Caries Active- Placebo Sodium Fluoride
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Cavities

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Florida College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Caries Free

Caries Free- Placebo

Caries Active

Caries Active- Placebo

Arm Description

Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned.

Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.

Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned.

Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.

Outcomes

Primary Outcome Measures

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.
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.
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.
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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 13, 2016
Last Updated
May 31, 2023
Sponsor
University of Florida
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT02999230
Brief Title
Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Official Title
Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Cavities

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caries Free
Arm Type
Active Comparator
Arm Description
Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned.
Arm Title
Caries Free- Placebo
Arm Type
Placebo Comparator
Arm Description
Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.
Arm Title
Caries Active
Arm Type
Active Comparator
Arm Description
Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned.
Arm Title
Caries Active- Placebo
Arm Type
Placebo Comparator
Arm Description
Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.
Intervention Type
Other
Intervention Name(s)
Caries Free 1.5% Arginine
Other Intervention Name(s)
1.5% Arginine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Caries Free Placebo Sodium Fluoride
Other Intervention Name(s)
Sodium Fluoride
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Caries Active 1.5% Arginine
Other Intervention Name(s)
1.5% Arginine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Caries Active- Placebo Sodium Fluoride
Other Intervention Name(s)
Sodium Fluoride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2
Description
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.
Time Frame
Changes from baseline to 2 weeks (Screening)
Title
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4
Description
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.
Time Frame
Changes from week 2 to week 4 (Baseline)
Title
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8
Description
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.
Time Frame
Changes from week 4 to week 8 (Washout)
Title
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12
Description
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
Time Frame
Changes from week 8 to week 12 (Evaluation)
Title
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.
Description
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.
Time Frame
Changes from baseline to week 12 (Evaluation)
Secondary Outcome Measure Information:
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2
Description
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.
Time Frame
Changes from baseline to week 2
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4
Description
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.
Time Frame
Changes from week 2 to week 4
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8
Description
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.
Time Frame
Changes from week 4 to week 8
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12
Description
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.
Time Frame
Changes from week 8 to week 12
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12
Description
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.
Time Frame
Changes from baseline to week 12
Other Pre-specified Outcome Measures:
Title
Salivary factors present in healthy and caries-active subjects during the research study.
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelle Nascimento, DDS, MS PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida College of Dentistry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health

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