Clinical trial NCT04197427: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Plaque
Gingivitis
Lead sponsor: You First Services
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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.

Primary outcomes:
measure: Effectiveness of the oral rinse in reducing plaque
timeFrame: 4 weeks
measure: Effectiveness of the oral rinse in reducing gingivitis
timeFrame: 4 weeks
measure: Effectiveness of the oral rinse in improving a patient's breath
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety evaluation of the test Oral Rinse
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
state: New York
Study officials:
References: