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

• 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: Completed
• Conditions: Oral Health
• Intervention / Treatment: Dietary supplement: Oral probiotic; Dietary supplement: Placebo

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: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Man Hung (Primary Investigator), PhD; Phone Number: 8018781270; Email: mhung@roseman.edu
• Study Contact Backup: Name: Rolando Maddela (Sponsor), MD, MPH; Phone Number: 19728397929; Email: rolando.maddela@usanainc.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Index	• 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	• 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

Outcome Measure	Measure Description	Time Frame
Halitosis	• 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	• 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	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	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

• Sponsor: USANA Health Sciences
• Collaborators: Roseman University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID 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