Clinical trial NCT05330793: The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
Official title: Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Lead sponsor: USANA Health Sciences
Sponsor class: INDUSTRY
Collaborators: name: Roseman University of Health Sciences
First posted: 2022-04-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Gingival Index
timeFrame: 8 weeks
measure: Plaque Index
timeFrame: 8 weeks
Secondary outcomes:
measure: Halitosis
timeFrame: 8 weeks
measure: Intraoral Imaging
timeFrame: 8 weeks
measure: SAQ
timeFrame: 8 weeks
measure: Microbial Community Analysis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: South Jordan
country: United States
facility: Roseman University of Health Sciences College of Dental Medicine
state: Utah
Study officials:
References: