Dry MouthNCT04189081

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

A study testing dry mouth rinse in people with Dry Mouth, run by Procter and Gamble at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Mouth
What is being tested?: dry mouth rinse
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 137 participants
Where: 1 siteUnited States
Study dates: 13 May 2020to 8 Jul 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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);

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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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Salus Research
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: A Clinical Study to Evaluate Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Water Control

Read the detailed 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).

Conditions: Dry Mouth
Being tested: dry mouth rinse, Water Control
Medical subject headings: Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dry mouth rinseDevice
relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Water ControlOther
negative control

Study groups in NCT04189081
Study group	Role	What they receive
Experimental Mouth Rinse	Experimental	dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. Receives: Device: dry mouth rinse
Water Control	Sham comparator	Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. Receives: Other: Water Control
Positive Control	Active comparator	dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. Receives: Device: dry mouth rinse

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 4-hours
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
Measured: 6-hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 20208 Jul 2020

First posted6 Dec 2019
Study start13 May 2020
Primary completion8 Jul 2020
Study completion8 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry MouthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04189081
Sponsor's protocol ID: CSD2019158
Status last verified: May 2021
First submitted: 4 Dec 2019
Last updated: 28 May 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Mouth trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Water Control
ClinicalTrials.gov ID: NCT04189081
Acronym / sponsor ID: CSD2019158
Conditions: Dry Mouth
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Study start: 13 May 2020 (actual)
Primary completion: 8 Jul 2020 (actual)
Study completion: 8 Jul 2020 (actual)
First posted: 6 Dec 2019 (actual)
Results: Posted 6 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Experimental Mouth Rinse	Experimental	Device: dry mouth rinsedry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
Water Control	Sham comparator	Other: Water ControlWater will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
Positive Control	Active comparator	Device: dry mouth rinsedry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dry mouth rinserelieves dry mouth symptoms by physically coating oral mucosal surfaces.	Device	Experimental Mouth Rinse, Positive Control
Water Controlnegative control	Other	Water Control

Primary outcome

Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Time frame: 4-hours
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
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Time frame: 6-hours
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

Results and safety

Results posted to the registry on 6 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Water Control	46	45
Experimental Mouth Rinse	45	45
Positive Control	46	45

Primary outcome: Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment

Time frame: 4-hours. Least squares mean (Standard Error). Unit: score on a scale

Measure	Water Control n = 46	Experimental Mouth Rinse n = 45	Positive Control n = 46
Value	2.51 (0.158)	3.26 (0.160)	3.43 (0.158)

Primary outcome: Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment

Time frame: 6-hours. Least squares mean (Standard Error). Unit: score on a scale

Measure	Water Control n = 46	Experimental Mouth Rinse n = 45	Positive Control n = 46
Value	2.70 (0.154)	3.46 (0.156)	3.36 (0.154)

Adverse events

Time frame: Products were used over 8 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Water Control	0 of 46 (0%)	3 of 46 (6.5%)	0 of 46
Experimental Mouth Rinse	0 of 45 (0%)	2 of 45 (4.4%)	0 of 45
Positive Control	0 of 46 (0%)	2 of 46 (4.3%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeff Milleman, DDS principal investigator

Procter and Gamble

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing dry mouth rinse in people with Dry Mouth, run by Procter and Gamble at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment (time frame: 4-hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04189081.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.