Back to resultsDetermination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
Primary Purpose
Plaque, Gingivitis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Oral Rinse
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Plaque
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Oral Rinse
Placebo Oral Rinse
Arm Description
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.
This arm will use a placebo with out the active ingredients same way the experimental arm do.
Outcomes
Primary Outcome Measures
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).
Effectiveness of the oral rinse in reducing gingivitis
Gingival health will be measured using the Modified Gingival Index (MGI)
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",
Secondary Outcome Measures
Safety evaluation of the test Oral Rinse
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04197427
Brief Title
Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
Official Title
Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
You First Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Oral Rinse
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Oral Rinse
Arm Type
Placebo Comparator
Arm Description
This arm will use a placebo with out the active ingredients same way the experimental arm do.
Intervention Type
Device
Intervention Name(s)
Experimental Oral Rinse
Intervention Description
Experimental Oral Rinse is a proprietary formulation of GRAS ingredients
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Placebo formulation without the active ingredients
Primary Outcome Measure Information:
Title
Effectiveness of the oral rinse in reducing plaque
Description
Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI).
Time Frame
4 weeks
Title
Effectiveness of the oral rinse in reducing gingivitis
Description
Gingival health will be measured using the Modified Gingival Index (MGI)
Time Frame
4 weeks
Title
Effectiveness of the oral rinse in improving a patient's breath
Description
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",
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety evaluation of the test Oral Rinse
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Ciancio, D.D.S
Phone
716-829-3848
Email
ciancio@buffalo.ed
Facility Information:
Facility Name
Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
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Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
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