NCT02130206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

April 25, 2014

Last Update Submit

November 7, 2016

Conditions

Dental Caries

Keywords

Plaque, Saliva, Cavities

Outcome Measures

Primary Outcomes (5)

  • 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.

    Changes from baseline to month 2 (Screening)

  • 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.

    Changes from month 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 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.

    Changes from week 4 to week 2 (Washout)

  • 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.

    Changes from week 2 to week 8 (Evaluation)

  • 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.

    Changes from week 8 to week 12 (Evaluation)

Secondary Outcomes (5)

  • Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to month 2

    Changes from baseline to month 2 (Screening)

  • Bacteria collected from oral samples of healthy and caries-active subjects changes from month 2 to week 4

    Changes from month 2 to week 4 (Baseline)

  • Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 2

    Changes from week 4 to week 2 (Washout)

  • Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 8

    Changes from week 2 to week 8 (Evaluation)

  • Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12

    Changes from week 8 to week 12 (Evaluation)

Other Outcomes (1)

  • Salivary factors present in healthy and caries-active subjects during the research study.

    Up to six months.

Study Arms (4)

Caries Free

ACTIVE COMPARATOR

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

Other: Caries Free

Caries Free - Placebo

PLACEBO COMPARATOR

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

Other: Caries Free - Placebo

Caries Active

ACTIVE COMPARATOR

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

Other: Caries Active

Caries Active - Placebo

PLACEBO COMPARATOR

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

Other: Caries Active - Placebo

Interventions

Caries FreeOTHER

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

Caries Free
Caries ActiveOTHER

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

Caries Active
Caries Free - PlaceboOTHER

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

Caries Free - Placebo
Caries Active - PlaceboOTHER

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

Caries Active - Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Dental CariesPlaque, Amyloid

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Marcelle Nascimento, DDS, MS, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2014

First Posted

May 5, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

US(1)