A Two-Week Study of an Anticavity Low pH Mouthwash (NCT06010758) | Clinical Trial Compass
CompletedPhase 4
A Two-Week Study of an Anticavity Low pH Mouthwash
United States163 participantsStarted 2023-07-17
Plain-language summary
The purpose of this clinical trial is to evaluate the oral tolerance of a new, experimental mouthwash compared to two mouth rinse formulations, which are already marketed, as well as compared to a tooth brushing only control group.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Able to comprehend and follow the requirements and restrictions of the clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) based upon research site personnel's assessment
* Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
* Able to read and understand the local language (participant is capable of reading the documents)
* Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect)
* Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics
* Evidence of being fully vaccinated for Coronavirus Disease 2019 (COVID-19) (adults 60 years and older)
* Negative pregnancy urine tests (females of child-bearing potential only)
* Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the clinical trial
* Resting baseline unstimulated salivary sample must be equal to or greater than 0.3 milliliters per minute (mL/min) to continue in the clinical trial
* A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly cariou…
What they're measuring
1
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues