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Probiotic

Probiotics for Tooth Decay

N/A
Waitlist Available
Led By Marcelle Nascimento, DDS, MS PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No contraindications to dental treatment
Twenty natural uncrowned teeth excluding third molars
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial will study how well probiotics and synbiotics work to control oral diseases, with a focus on preventing or treating cavities.

Who is the study for?
This trial is for individuals with healthy teeth or those with tooth decay. Participants must have at least 20 natural teeth without crowns and not use tobacco products. They can't be immune compromised, on certain medications, or have participated in another clinical study recently.Check my eligibility
What is being tested?
The study tests probiotics that could help prevent and treat cavities by moderating pH levels in the mouth. It compares the effects of a caries-active agent (1.5% Arginine) against a placebo (Sodium Fluoride) in both cavity-free and cavity-affected participants.See study design
What are the potential side effects?
While specific side effects are not detailed, typical risks may include allergic reactions to ingredients, minor oral discomfort or changes in taste sensation due to the interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no health issues preventing dental treatments.
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I have 20 natural teeth without crowns, not counting wisdom teeth.
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I have no current or past signs of tooth decay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4
+2 more
Secondary outcome measures
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12
Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2
Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4
+2 more
Other outcome measures
Salivary factors present in healthy and caries-active subjects during the research study.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Caries FreeActive Control1 Intervention
Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned.
Group II: Caries ActiveActive Control1 Intervention
Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned.
Group III: Caries Free- PlaceboPlacebo Group1 Intervention
Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.
Group IV: Caries Active- PlaceboPlacebo Group1 Intervention
Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,474 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
297 Previous Clinical Trials
847,078 Total Patients Enrolled
Marcelle Nascimento, DDS, MS PhDPrincipal InvestigatorUniversity of Florida

Media Library

Probiotics (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02999230 — N/A
Tooth Decay Research Study Groups: Caries Free, Caries Free- Placebo, Caries Active, Caries Active- Placebo
Tooth Decay Clinical Trial 2023: Probiotics Highlights & Side Effects. Trial Name: NCT02999230 — N/A
Probiotics (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02999230 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective of this clinical trial?

"This clinical trial, to be evaluated over a two week period, aims to evaluate the fluctuation in ADS levels from baseline and further assess the ability of bacteria present in oral samples taken at weeks 2, 4 and 8 to produce ammonia from arginine under varying environmental conditions. Secondary outcomes include observing changes in bacterial composition collected during these visits."

Answered by AI

Is this research program open to individuals aged 80 or above?

"The inclusion requirements of this clinical trial states that participants must be between 18 and 65 years old. There are currently 55 studies underway specifically for those younger than 18, while 31 trials accommodate older adults over the age of 65."

Answered by AI

Who is eligible to partake in this experiment?

"Eligible candidates for this clinical trial must be suffering from dental caries and between 18 to 65 years of age. Currently, the study seeks 170 participants."

Answered by AI

Are there still openings for this trial?

"According to clinicaltrials.gov, this medical trial has ceased recruiting patients; although the initial listing was published in February 2017 and last updated on June 9th of 2022, it is no longer seeking participants. Fortunately, there are presently 103 other studies actively enrolling volunteers."

Answered by AI
~21 spots leftby Mar 2025