Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oral Health
- Sponsor
- USANA Health Sciences
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Gingival Index
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
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.
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
- Intraoral Imaging(8 weeks)
- Microbial Community Analysis(8 weeks)
- Halitosis(8 weeks)
- SAQ(8 weeks)