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N/A N=137 Randomized Double-blind Treatment

Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control

Dry Mouth

Enrolled (actual)
137
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment — 2.51; 3.26; 3.43 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
dry mouth rinse (Device); Water Control (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Procter and Gamble
Primary completion
Jul 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
2.70; 3.46; 3.36
PRIMARY
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
2.70; 3.46; 3.36

Summary

The objective of this study is to evaluate dry mouth relief in subjects with self-reported feeling of dry mouth after using an experimental mouth rinse or a positive control compared to a water control.

Eligibility Criteria

Inclusion Criteria

  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Sign a Confidentiality Disclosure Agree(CDA) form and be given a signed copy;
  • Be at least 18 years of age;
  • 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 eating, drinking, smoking, using oral care products, using tobacco, using a medicated lozenge, chewing gum, or breath mints during the 6-hour test period (except snack after 4-hour Questionnaire);
  • Agree to return for all scheduled visits and to follow all study procedures.

Exclusion Criteria

  • 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;
  • 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); or
  • Evidence of gross intra-oral neglect or need for extensive dental therapy.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04189081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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