A Study to Investigate Salivary Flow and Potential of Hydrogen (pH) Following Use of Essential-Oi… (NCT06136455) | Clinical Trial Compass
CompletedPhase 4
A Study to Investigate Salivary Flow and Potential of Hydrogen (pH) Following Use of Essential-Oil Containing Mouthwashes
United States164 participantsStarted 2023-11-13
Plain-language summary
The purpose of this trial is to evaluate the amount of saliva generated and changes in the oral Potential of Hydrogen (pH) after a single use of essential oil (EO)-containing mouth rinses compared to a negative control. Three EO mouthwash formulations will be investigated in this regard, with the negative control being tap water.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \[that is (i.e.), brush teeth daily and exhibit no signs of oral neglect\]
* 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 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 mL/min to continue in the clinical trial
* A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically ba…
What they're measuring
1
Salivary Flow Rate
Timeframe: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
2
Saliva Potential of Hydrogen (pH)
Timeframe: Taken at Baseline and at 2.5, 5, 10, 15, and 30 minute timepoints