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

USANA Health Sciences

Status: Completed

Conditions: Oral Health

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Oral probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05330793

202001

Details and patient eligibility

About

• 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

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

: Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)

Other group

Description:

1 active oral probiotic with placebo toothpaste

Treatment:

Dietary Supplement: Oral probiotic

Dietary Supplement: Placebo

Oral probiotic lozenges + toothpaste with ADP-1

Active Comparator group

Description:

Oral probiotic and ADP1 toothpaste

Treatment:

Dietary Supplement: Oral probiotic

Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)

Placebo Comparator group

Description:

Placebo without oral probiotics or ADP1 toothpaste

Treatment:

Dietary Supplement: Placebo