Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04189081
Other study ID # CSD2019158
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2020
Est. completion date July 8, 2020

Study information

Verified date May 2021
Source Procter and Gamble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a controlled, randomized, 3-treatment, parallel study for subjects with self-reported dry mouth symptoms as determined by an Oral Examination and subject responses to the Dry Mouth Inventory (DMI) questionnaire (see section 12) at the Acclimation visit. Qualified subjects will be randomly assigned to one of three treatments at the Baseline visit. Safety will be assessed by Oral Examinations at Baseline/Day1 and Day 8. Subjects will complete questionnaires before product use, immediately after product use (Day 1 only), and after 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours of product use on Baseline/Day 1 and Day 8. The PPAQ II questionnaire will be completed on the morning of Day 8 (see study schedule for details).


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date July 8, 2020
Est. primary completion date July 8, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
dry mouth rinse
relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Other:
Water Control
negative control

Locations

Country Name City State
United States Salus Research Fort Wayne Indiana

Sponsors (1)

Lead Sponsor Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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 Product Performance and Attributes (PPAQ I)
Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:
1) Relieves the discomfort of your dry mouth
4-hours
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 Product Performance and Attributes (PPAQ I)
Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:
1) Relieves the discomfort of your dry mouth
6-hours
See also
  Status Clinical Trial Phase
Completed NCT04914208 - Effect of Wearing Face Masks on Salivary Parameters and Halitosis N/A
Completed NCT00601874 - Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fasting Conditions N/A
Completed NCT00601211 - Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions N/A
Completed NCT04152642 - A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse N/A
Completed NCT03215251 - Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients in ICUs N/A
Completed NCT04632004 - Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health N/A
Completed NCT05640362 - Efficacy of Natural Enzymes Mouthwash: a Randomised Controlled Trial N/A
Not yet recruiting NCT06412627 - The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube N/A
Completed NCT04986501 - Clinical Evaluation of MucoPEG™ for Xerostomia N/A
Completed NCT05871580 - Effect to the Photobiomodulation in the Burning Mouth Syndrome N/A
Completed NCT06258603 - Oral Care of Intubated Intensive Care Patient N/A
Completed NCT01737307 - Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy Phase 2
Completed NCT01647737 - Green Tea Lozenges for the Management of Dry Mouth Phase 1/Phase 2
Active, not recruiting NCT03874572 - Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth Phase 1
Completed NCT03035825 - Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients N/A
Recruiting NCT05964959 - A Mouth Education Program for Dry Mouth N/A
Withdrawn NCT02123147 - Examining the Immunological Process of Autoimmune Patients N/A
Completed NCT01885065 - Efficacy of Novel Edible Gel-based Artificial Saliva in Cancer Patients N/A
Completed NCT03281486 - "Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth N/A
Not yet recruiting NCT05506137 - Xerostomia in Patients With a Life-limiting Condition or Frailty Phase 3