PlaqueNCT04197427
Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
A study testing Experimental Oral Rinse in people with Plaque and Gingivitis, run by You First Services at 1 site in United States.
Trial summary
Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Gingivitis
- What is being tested?
- Experimental Oral Rinse
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 31 Dec 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
- Subject is between the ages of 18 and 75 years inclusive.
- Subject will not have professional cleaning during the study.
- Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
- Subject has a minimum of 12 natural teeth.
Show all 10Show fewer
- Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
- Subject agrees to refrain from the use of other oral care products not supplied by the study center
- Subject agrees to be compliant with study procedures.
- Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy
Who cannot join
- Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
- Subject is between the ages of 18 and 75 years inclusive.
- Subject will not have professional cleaning during the study.
- Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
- Subject has a minimum of 12 natural teeth.
Show all 10Show fewer
- Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
- Subject agrees to refrain from the use of other oral care products not supplied by the study center
- Subject agrees to be compliant with study procedures.
- Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
Buffalo, New York, 14214
About this study
Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath
Read the detailed description
This clinical study design is a randomized, double-blind, single-treatment, parallel design with a placebo as the control. Following a screening exam, the duration of the trial will be 1 month. Oral examinations will occur at Visit 1 (baseline), and Visit 2 (4 weeks post screening). Also, at these visits, subjects will be asked keep a diary for the one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness". They will also be asked about the taste and consistency of the mouth rinse. Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). Gingival health will be measured using the Modified Gingival Index (MGI)
- Conditions
- Plaque, Gingivitis
- Being tested
- Experimental Oral Rinse, Placebo
- Medical subject headings
- Plaque, Amyloid, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Oral RinseDevice
Experimental Oral Rinse is a proprietary formulation of GRAS ingredients
PlaceboDevice
Placebo formulation without the active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Experimental Oral Rinse | Experimental | In this arm the test article,oral rinse, a proprietary formulation of agents including xylitol, Caffeine, Essential oils, Monk fruit extract, which can reduce the plaque formation Subjects rinse twice a day with 10 mL of the oral rinse for 2 minutes for 30 days.
They will note, in the daily oral hygiene diary, the date and time of brushing and rinsing. Receives: Device: Experimental Oral Rinse |
| Placebo Oral Rinse | Placebo comparator | This arm will use a placebo with out the active ingredients same way the experimental arm do. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the oral rinse in reducing plaque
Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI).
Measured: 4 weeks
Effectiveness of the oral rinse in reducing gingivitis
Gingival health will be measured using the Modified Gingival Index (MGI)
Measured: 4 weeks
Effectiveness of the oral rinse in improving a patient's breath
Subjects will be asked keep a diary for one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness",
Measured: 4 weeks
Secondary outcomes (1)
Safety evaluation of the test Oral Rinse
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Mar 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlaqueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- You First Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197427
- Sponsor's protocol ID
- SW-101-19
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
- ClinicalTrials.gov ID
- NCT04197427
- Acronym / sponsor ID
- SW-101-19
- Conditions
- Plaque, Gingivitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- You First ServicesIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Dec 2019 (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.
Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath
Detailed description
This clinical study design is a randomized, double-blind, single-treatment, parallel design with a placebo as the control. Following a screening exam, the duration of the trial will be 1 month. Oral examinations will occur at Visit 1 (baseline), and Visit 2 (4 weeks post screening). Also, at these visits, subjects will be asked keep a diary for the one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness". They will also be asked about the taste and consistency of the mouth rinse. Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). Gingival health will be measured using the Modified Gingival Index (MGI)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Oral Rinse | Experimental | Device: Experimental Oral RinseIn this arm the test article,oral rinse, a proprietary formulation of agents including xylitol, Caffeine, Essential oils, Monk fruit extract, which can reduce the plaque formation Subjects rinse twice a day with 10 mL of the oral rinse for 2 minutes for 30 days. They will note, in the daily oral hygiene diary, the date and time of brushing and rinsing. |
| Placebo Oral Rinse | Placebo comparator | Device: PlaceboThis arm will use a placebo with out the active ingredients same way the experimental arm do. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
- Subject is between the ages of 18 and 75 years inclusive.
- Subject will not have professional cleaning during the study.
- Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
Key exclusion criteria (10 listed)
- Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
- Subject is between the ages of 18 and 75 years inclusive.
- Subject will not have professional cleaning during the study.
- Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
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 |
|---|---|---|
| Experimental Oral RinseExperimental Oral Rinse is a proprietary formulation of GRAS ingredients | Device | Experimental Oral Rinse |
| PlaceboPlacebo formulation without the active ingredients | Device | Placebo Oral Rinse |
Primary outcome
Effectiveness of the oral rinse in reducing plaque
Time frame: 4 weeks
Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI).
Effectiveness of the oral rinse in reducing gingivitis
Time frame: 4 weeks
Gingival health will be measured using the Modified Gingival Index (MGI)
Effectiveness of the oral rinse in improving a patient's breath
Time frame: 4 weeks
Subjects will be asked keep a diary for one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness",
1 secondary outcome
Safety evaluation of the test Oral Rinse
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Oral Rinse in people with Plaque and Gingivitis, run by You First Services 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Ciancio, D.D.S (716-829-3848, ciancio@buffalo.ed), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the oral rinse in reducing plaque (time frame: 4 weeks). The study lists 3 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 17 Dec 2019.