A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse
Completed · Not applicable
Conditions studied: Dry Mouth
In brief
The objective of this pilot study is to determine if an experimental mouth rinse and a marketed dry mouth rinse are more effective in relieving dry mouth compared to water.
Key facts
- Study ID
- NCT04152642
- Run by
- Procter and Gamble
- People needed
- 22
- Starts
- 2019-11-04
- Expected to finish
- 2019-12-05
- Last updated by the study team
- 2021-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be at least 18 years of age;
- Be in good general health as determined by the Investigator/designee;
- Agree not to participate in any other oral care studies for the duration of this study;
- Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
- Agree to refrain from the use of any non-study oral hygiene products for the study duration including mouth rinse and toothpaste (flossing is permitted if part of their normal routine);
- Self-report a dry mouth feeling according to the modified DMI questions. (Subject must answer at least 2 out of 4 questions with 'agree a little,' 'agree' or 'strongly agree');
- Agree to refrain from smoking, drinking, using tobacco products, using breath mints, medicated lozenges, or chewing gum during the 4-hour test period;
- Agree to return for all scheduled visits and to follow all study procedures.
You may not qualify if…
- Any condition or disease, as determined by the Investigator/Designee, that could be expected to interfere with examination procedures, with compliance, or with the subject's safe completion of the study;
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for periodontitis;
- Having a history of allergies or hypersensitivity to mouth rinse or ingredients in commercial dental products or cosmetics;
- Self-reported pregnancy or the intent to become pregnant during the study, or breast feeding;
- Full or partial dentures or any orthodontic appliances such as braces or aligners, or tongue or mouth piercing;
- Having diabetes;
- Inability to undergo any study procedure;
- Having untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g., current oral ulceration);
- Use of prescription systemic parasympathetic medications (e.g., Pilocarpine), for the treatment of the feeling of dry mouth;
- Currently under the care of a dental/medical professional specifically for the treatment of dry mouth (at the discretion of the Investigator/Designee);
- Self-reported mouth breathers (i.e., mouth breathing secondary to nasal obstruction);
- Evidence of gross intra-oral neglect or need for extensive dental therapy; or
- Currently undergoing radiotherapy and/or chemotherapy treatment.
Where it is running
- Procter & Gamble — Mason, Ohio, United States
Full record on ClinicalTrials.gov
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