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A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse

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ClinicalTrials.gov Identifier: NCT04152642
Recruitment Status : Completed
First Posted : November 5, 2019
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Tracking Information
First Submitted Date  ICMJE November 1, 2019
First Posted Date  ICMJE November 5, 2019
Results First Submitted Date  ICMJE November 9, 2020
Results First Posted Date  ICMJE February 2, 2021
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE November 4, 2019
Actual Primary Completion Date December 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 [ Time Frame: 2-hour, Day 4 ]
Product Performance and Attributes (PPAQ I) Question #1: Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse
Official Title  ICMJE A Pilot Clinical Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Negative Control
Brief Summary 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.
Detailed Description This is a controlled, randomized, 3-treatment, 3-period crossover study in subjects with self-reported dry mouth symptoms as determined by subject responses (as determined by the response to "relieving the discomfort of dry mouth" question from the modified Product Performance and Attributes Questionnaire I/ Moisturization and Dryness (PPAQ I/ MD)) compared to water. Subjects enrollment is based on the responses to the Dry Mouth Inventory (DMI). A sufficient number of volunteers will be screened to ensure enrollment of up to 30 subjects at Acclimation. Subjects who meet the eligibility criteria will continue into the treatment phase of the study. Safety will be assessed by Oral examinations at Baseline/Day1 and Day 4. Subjects will complete questionnaires at Baseline (before product use Day 1 only), after immediate use, 30 minutes, 1 hour, 2 hours, and 4 hours after supervised product use on Day 1 and Day 4 of each period. The PPAQ II questionnaire will be completed in the morning of Day 4 of each period. Subjects will be randomly assigned to treatment sequences at the Baseline visit of Period 1. The treatment and washout periods will be repeated until all three treatment periods have been completed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
3-treatment crossover, with 4 days of use
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Mouth
Intervention  ICMJE
  • Device: Marketed Dry Mouth Rinse
    relieves dry mouth symptoms by physically coating oral mucosal surfaces.
  • Other: Water control
    negative control
  • Device: Experimental Dry Mouth Rinse
    relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Study Arms  ICMJE
  • Active Comparator: Marketed Mouth Rinse
    dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.
    Intervention: Device: Marketed Dry Mouth Rinse
  • Experimental: Experimental Mouth Rinse
    dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.
    Intervention: Device: Experimental Dry Mouth Rinse
  • Sham Comparator: Water/Negative Control
    subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.
    Intervention: Other: Water control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2020)
22
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 5, 2019
Actual Primary Completion Date December 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

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;
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04152642
Other Study ID Numbers  ICMJE CSD2019138
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Procter and Gamble
Study Sponsor  ICMJE Procter and Gamble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Malgorzata Klukowska, DDS Procter and Gamble
PRS Account Procter and Gamble
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP