Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Plaque, Gingivitis
In brief
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
Key facts
- Study ID
- NCT04197427
- Run by
- You First Services
- People needed
- 62
- Starts
- 2020-03-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2019-12-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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