The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste

April 19, 2023 updated by: USANA Health Sciences

Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste

  • Randomized double-blind, placebo-controlled trial on the effects of an oral probiotic intervention with or without a novel ADP-1 toothpaste Objective
  • Determine the safety and effectiveness of oral probiotic intervention with or without a novel toothpaste and compare with placebo

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypotheses:

  1. Subjects using oral probiotics will have better oral health than subjects using placebo toothpaste and placebo lozenges.
  2. Subjects using oral probiotics and ADP-1 toothpaste will have better oral health than subjects using oral probiotics and regular toothpaste, and subjects using regular toothpaste and placebo lozenges.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Man Hung (Primary Investigator), PhD
  • Phone Number: 8018781270
  • Email: mhung@roseman.edu

Study Contact Backup

Study Locations

  • United States
    • Utah
      • South Jordan, Utah, United States, 84095
        • Roseman University of Health Sciences College of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 18 to 65 years old
  • Fluent in English
  • Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm)
  • Bleeding on probing on 30%+ areas
  • Able to perform oral hygiene adequately after formal instructions
  • Able to understand and comply with study procedure
  • Able to provide written informed consent
  • Able to come to Roseman Dental Clinics in South Jordan for a 90-minute pre-screening to determine eligibility
  • Able to complete five (90-minute) clinic visits in 2-week intervals

Exclusion Criteria:

  • • Probing depths less than 3mm

    • Breastfeeding, pregnant or trying to become pregnant

    • Currently taking or have taken any of the following within 30 days of enrollment:

      • Oral probiotics
      • Antibiotic medications
      • Antifungal medications (e.g., nystatin, clotrimazole, ketoconazole, griseofulvin)
      • Antiseptic medications
      • Immunosuppressant and/or chemotherapeutic medications
      • Medications that could affect gum response measurement (e.g., calcium channel blockers, cyclosporin, anti-seizures like phenytoin and related drugs, anti-inflammatory agents)
    • Frequent alcohol consumption (> 2 drinks per day, or > 8 per week for women, or > 15 per week for men)
    • Use of marijuana (which can cause dry mouth or other conditions) or recreational drugs
    • Use of tobacco products including chewing tobacco and all types of cigarettes (e-cigarettes)
    • Known allergy to any product ingredient (ingredient list provided by USANA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)
1 active oral probiotic with placebo toothpaste
Dietary supplement: Oral probiotic
an oral probiotic intervention with or without a novel ADP1 toothpaste
Other Names:
  • ADP1 toothpaste
Dietary supplement: Placebo
placebo without Oral probiotic or toothpaste
Active Comparator: Oral probiotic lozenges + toothpaste with ADP-1
Oral probiotic and ADP1 toothpaste
Dietary supplement: Oral probiotic
an oral probiotic intervention with or without a novel ADP1 toothpaste
Other Names:
  • ADP1 toothpaste
Placebo Comparator: Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)
Placebo without oral probiotics or ADP1 toothpaste
Dietary supplement: Placebo
placebo without Oral probiotic or toothpaste

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gingival Index
Time Frame: 8 weeks
• Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
8 weeks
Plaque Index
Time Frame: 8 weeks
• Plaque index is used as a method of recording the presence of plaque on individual tooth surfaces. These surfaces are mesial, distal, buccal and lingual.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Halitosis
Time Frame: 8 weeks
• Halitosis will be measured using a digital bad breath checker. The instrument is a small device with a sensor that sits near your mouth. This instrument senses volatile sulfur compounds or VSCs and produces a parts-per-billion (ppb) measurement of the foul-smelling compounds.
8 weeks
Intraoral Imaging
Time Frame: 8 weeks
• Intraoral imaging of tooth decay can be measured in at least one of the following methods: (1) Using traditional intraoral imaging camera in the dental clinics to visualize tooth decay on the tooth surface, and (2) Using a laser fluorescence pen to detect tooth decay.
8 weeks
SAQ
Time Frame: 8 weeks
Self-Assessment Questionnaire will consist of no more than 100 questions examining quality of life across one or several of these domains: (1) social well-being, (2) mental well-being, (3) physical well-being, (4) oral health and (5) dental hygiene and halitosis.dental hygiene and halitosis.
8 weeks
Microbial Community Analysis
Time Frame: 8 weeks
Oral swabs from the gum line will be collected using DNA Genotek OMNIgene-ORAL swab kits and stored in the accompanying swab storage tube for microbial community analysis. qPCR testing will be performed in house in USANA.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USANA Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roseman University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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