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The Microbiology of Caries Resistance

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Caries Free
Caries Active
Caries Free - Placebo
Caries Active - Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Caries focused on measuring Plaque, Saliva, Cavities

Eligibility Criteria

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

Inclusion Criteria:

  • Twenty natural teeth excluding third molars
  • No contraindications to dental treatment
  • Caries Free
  • Caries Active (at least two active sites)

Exclusion Criteria:

  • Less that twenty teeth
  • Any systemic disease that can cause xerostomia
  • Taking medications that cause xerostomia
  • Antibiotics last three months
  • Advanced Periodontal Disease
  • Removable or fixed dental appliances
  • Bleeding disorders or taking anticoagulant medications
  • Immune compromised individuals
  • Participating in another research study
  • Used flavored products such as mint flavored candies and chewing gum one week prior to or during the study
  • Uses tobacco products
  • Unwilling or unable to provide Informed Consent and follow 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. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.

Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.

Gums will be examined. On some visits Saliva and 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 month 2
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from month 2 to week 4
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 2
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 8
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
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 study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.

Secondary Outcome Measures

Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to month 2
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Bacteria collected from oral samples of healthy and caries-active subjects changes from month 2 to week 4
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 2
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 8
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
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 baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.

Full Information

First Posted
April 25, 2014
Last Updated
November 7, 2016
Sponsor
University of Florida
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT02130206
Brief Title
The Microbiology of Caries Resistance
Official Title
The Microbiology of Caries Resistance. Subtitle: Functional Amyloid Formation in Streptococcus Mutans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Colgate Palmolive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to investigate the bacterial composition of plaque and saliva located in the mouth and associate that with risk factors that cause cavities.
Detailed Description
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. 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 your 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
Plaque, Saliva, Cavities

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caries Free
Arm Type
Active Comparator
Arm Description
Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
Arm Title
Caries Free - Placebo
Arm Type
Placebo Comparator
Arm Description
Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
Arm Title
Caries Active
Arm Type
Active Comparator
Arm Description
Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
Arm Title
Caries Active - Placebo
Arm Type
Placebo Comparator
Arm Description
Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
Intervention Type
Other
Intervention Name(s)
Caries Free
Intervention Description
Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
Intervention Type
Other
Intervention Name(s)
Caries Active
Intervention Description
Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
Intervention Type
Other
Intervention Name(s)
Caries Free - Placebo
Intervention Description
Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
Intervention Type
Other
Intervention Name(s)
Caries Active - Placebo
Intervention Description
Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
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 month 2
Description
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Time Frame
Changes from baseline to month 2 (Screening)
Title
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from month 2 to week 4
Description
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Time Frame
Changes from month 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 2
Description
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Time Frame
Changes from week 4 to week 2 (Washout)
Title
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 8
Description
Saliva and dental plaque will be collected during the study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Time Frame
Changes from week 2 to week 8 (Evaluation)
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 study visit. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured using a standardized protocol.
Time Frame
Changes from week 8 to week 12 (Evaluation)
Secondary Outcome Measure Information:
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to month 2
Description
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Time Frame
Changes from baseline to month 2 (Screening)
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from month 2 to week 4
Description
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Time Frame
Changes from month 2 to week 4 (Baseline)
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 2
Description
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Time Frame
Changes from week 4 to week 2 (Washout)
Title
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 8
Description
Saliva and dental plaque will be collected during the baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Time Frame
Changes from week 2 to week 8 (Evaluation)
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 baseline study visit. These oral samples will be plated in specific medium for bacterial growth and isolation. The isolated bacteria will be identified by molecular and microbiological techniques to characterize their capacity to produce ammonia from arginine - ADS activity. Protocols will be used to determine the sensitivity of the ADS of the oral isolates to environmental oral factors.
Time Frame
Changes from week 8 to week 12 (Evaluation)
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. Microbiological and molecular techniques such as microscopic observation of green birefringence, elisa assays and microRNA analysis will be used to determine and compare differences between salivary factors present in these two groups
Time Frame
Up to six 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 teeth excluding third molars No contraindications to dental treatment Caries Free Caries Active (at least two active sites) Exclusion Criteria: Less that twenty teeth Any systemic disease that can cause xerostomia Taking medications that cause xerostomia Antibiotics last three months Advanced Periodontal Disease Removable or fixed dental appliances Bleeding disorders or taking anticoagulant medications Immune compromised individuals Participating in another research study Used flavored products such as mint flavored candies and chewing gum one week prior to or during the study Uses tobacco products Unwilling or unable to provide Informed Consent and follow 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

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The Microbiology of Caries Resistance

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