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

Not Applicable

Completed

• Conditions: Oral Health

• Registration Number: NCT05330793
• Lead Sponsor: USANA Health Sciences

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

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 Timeline

• Study Start: 2021-10-26
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-15
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Roseman University of Health Sciences College of Dental Medicine; 🇺🇸 South Jordan, Utah, United States