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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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