Oral HealthNCT05330793
The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
A study testing Oral probiotic in people with Oral Health, run by USANA Health Sciences at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Oral probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- • 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roseman University of Health Sciences College of Dental Medicine
South Jordan, Utah, 84095
About this study
Official title: Randomized Double-blind, Placebo-controlled Trial on 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
Read the detailed description
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.
- Conditions
- Oral Health
- Being tested
- Oral probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral probioticDietary supplement
Also called ADP1 toothpaste
an oral probiotic intervention with or without a novel ADP1 toothpaste
PlaceboDietary supplement
placebo without Oral probiotic or toothpaste
| Study group | Role | What they receive |
|---|---|---|
| : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1) | Other | 1 active oral probiotic with placebo toothpaste Receives: Dietary Supplement: Oral probiotic; Dietary Supplement: Placebo |
| Oral probiotic lozenges + toothpaste with ADP-1 | Active comparator | Oral probiotic and ADP1 toothpaste Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start26 Oct 2021
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- USANA Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roseman University of Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330793
- Sponsor's protocol ID
- 202001
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: YES
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind, Placebo-controlled Trial on the Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste
- ClinicalTrials.gov ID
- NCT05330793
- Acronym / sponsor ID
- 202001
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- USANA Health SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Roseman University of Health Sciences
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1) | Other | Dietary Supplement: Oral probiotic, Dietary Supplement: Placebo1 active oral probiotic with placebo toothpaste |
| Oral probiotic lozenges + toothpaste with ADP-1 | Active comparator | Dietary Supplement: Oral probioticOral probiotic and ADP1 toothpaste |
| Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1) | Placebo comparator | Dietary Supplement: PlaceboPlacebo without oral probiotics or ADP1 toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- • Probing depths less than 3mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral probioticAlso: ADP1 toothpastean oral probiotic intervention with or without a novel ADP1 toothpaste | Dietary supplement | : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1), Oral probiotic lozenges + toothpaste with ADP-1 |
| Placeboplacebo without Oral probiotic or toothpaste | Dietary supplement | : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1), Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1) |
Primary outcome
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.
4 secondary outcomes
Halitosis
Time frame: 8 weeks
Intraoral Imaging
Time frame: 8 weeks
SAQ
Time frame: 8 weeks
Microbial Community Analysis
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: Undecided. YES
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral probiotic in people with Oral Health, run by USANA Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.