Status:
COMPLETED
The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
Lead Sponsor:
USANA Health Sciences
Collaborating Sponsors:
Roseman University of Health Sciences
Conditions:
Oral Health
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 hav...
Eligibility Criteria
Inclusion
- 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
- • 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)
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05330793
Start Date
October 26 2021
End Date
December 16 2022
Last Update
April 21 2023
Active Locations (1)
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1
Roseman University of Health Sciences College of Dental Medicine
South Jordan, Utah, United States, 84095