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

Oral Health Clinical Trial

Official title:

Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05330793
• Other study ID #: 202001
• Status: Completed
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: April 2023
• Source: USANA Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Oral Health

Intervention

Dietary Supplement:
• Oral probiotic
an oral probiotic intervention with or without a novel ADP1 toothpaste
• Placebo
placebo without Oral probiotic or toothpaste

Locations

Country	Name	City	State
United States	Roseman University of Health Sciences College of Dental Medicine	South Jordan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
USANA Health Sciences	Roseman University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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