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

NCT05330793 | Completed DMC

• 1 other identifier: 202001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Health

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Halitosis

  8 weeks

• Intraoral Imaging

  8 weeks

• SAQ

  8 weeks

• Microbial Community Analysis

  8 weeks

Study Arms (3)

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

OTHER

1 active oral probiotic with placebo toothpaste

Dietary Supplement: Oral probiotic; Dietary Supplement: Placebo

Oral probiotic lozenges + toothpaste with ADP-1

ACTIVE COMPARATOR

Oral probiotic and ADP1 toothpaste

Dietary Supplement: Oral probiotic

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

PLACEBO COMPARATOR

Placebo without oral probiotics or ADP1 toothpaste

Dietary Supplement: Placebo

Interventions

Oral probiotic DIETARY_SUPPLEMENT

an oral probiotic intervention with or without a novel ADP1 toothpaste

Also known as: ADP1 toothpaste

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

Placebo DIETARY_SUPPLEMENT

placebo without Oral probiotic or toothpaste

: Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1); Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• USANA Health Sciences: lead
• Roseman University of Health Sciences: collaborator

Study Sites (1)

Roseman University of Health Sciences College of Dental Medicine

South Jordan, Utah, 84095, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 15, 2022
• Study Start: October 26, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

US (1)