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Completed

NCT Number: NCT05330793

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

* 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

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Key information

Conditions

Oral Health

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roseman University of Health Sciences College of Dental Medicine

South Jordan, Utah, 84095, United States

About this study

Hypotheses:

  • Subjects using oral probiotics will have better oral health than subjects using placebo toothpaste and placebo lozenges.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral probiotic

Dietary Supplement

an oral probiotic intervention with or without a novel ADP1 toothpaste

Other names: ADP1 toothpaste

Placebo

Dietary Supplement

placebo without Oral probiotic or toothpaste

Primary outcomes

  1. Gingival Index

    Time frame: 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.

  2. Plaque Index

    Time frame: 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 outcomes

  1. Halitosis

    Time frame: 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.

  2. Intraoral Imaging

    Time frame: 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.

  3. SAQ

    Time frame: 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.

  4. Microbial Community Analysis

    Time frame: 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.

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

USANA Health Sciences

Industry

Collaborators

  • Roseman University of Health Sciences

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2022
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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