Clincosm LogoSign in Get a demo

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

Sponsor
USANA Health Sciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05330793
Collaborator
Roseman University of Health Sciences (Other)
105
Enrollment
1
Location
3
Arms
12.2
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  • 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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Oral probiotic
  • Dietary Supplement: Placebo
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of an oral probiotic intervention with or without a novel toothpaste and compared with placebo toothpaste and placebo lozenges.This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of an oral probiotic intervention with or without a novel toothpaste and compared with placebo toothpaste and placebo lozenges.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
Actual Study Start Date :
Oct 26, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Gingival Index [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.

    2. Plaque Index [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.

    Secondary Outcome Measures

    1. Halitosis [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.

    2. Intraoral Imaging [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.

    3. SAQ [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.

    4. Microbial Community Analysis [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roseman University of Health Sciences College of Dental Medicine South Jordan Utah United States 84095

    Sponsors and Collaborators

    • USANA Health Sciences
    • Roseman University of Health Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    USANA Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05330793
    Other Study ID Numbers:
    • 202001
    First Posted:
    Apr 15, 2022
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 15, 2022