Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

September 30, 2024 updated by: Solventum US LLC

An Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray on the Relief of Dry Mouth Symptoms

The purpose of the clinical trial is to evaluate and validate the performance of the experimental mouth spray when used by persons with mild to severe dry mouth symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to investigate the efficacy of 3M Dry Mouth Moisturizing Spray to reduce symptoms of dry mouth for up to 4 hours and after 7 days of use. In addition, this study aims to support comparative claims.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • LOMA LINDA UNIVERSITY, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Screening - Start of Wash-In Visit

  • Subject who is ≥18 years of age and complains of dry mouth
  • Only 1 subject per household is allowed into study
  • Subject with a Challacombe scale score of 1 or higher
  • Subject agrees to refrain from eating spicy foods and foods containing garlic beginning 48-hours prior to all study visits
  • Subject agrees to eat a meal prior to all study visits that include sample evaluation in the clinic
  • Subject agrees to not eat, drink, chew tobacco, chew gum, smoke, brush or floss teeth for 2-hours prior to sample evaluation study visits
  • Subject agree to not use any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
  • Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
  • Subject agrees to only use those clinical oral care supplies provided during the entire study
  • Able to understand and willing to sign the Informed Consent Form

Water Only Evaluation Visit

  • Subject has successfully completed a ≥ 2-day wash-in period
  • Subject has Challacombe scale score of 1 or higher
  • Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to the sample evaluation visits
  • Subject ate a meal prior to sample evaluation study visits
  • Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
  • Subject has not used any oral care products, any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
  • Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
  • Subject has used only those clinical oral care supplies provided during study

Baseline Period 1/Randomization Visit

  • Subject has successfully completed a ≥ 2-day wash-in period
  • Subject has a Challacombe Scale score of 1 or higher
  • Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to sample evaluation study visits
  • Subject ate a meal prior to sample evaluation study visits
  • Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
  • Subject has not used any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
  • Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
  • Subject has used only those clinical oral care supplies provided during study

Exclusion Criteria:

Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and Baseline Period 1 (Randomization Visit)

  • Subject has active mouth sores (e.g., cold sores, cuts, burns, canker sores)
  • Subject has a life-threatening pathological condition
  • Subject is participating in another clinical trial at the time of the study
  • Subject has profound marginal periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
  • Medical and oral conditions that, in the investigator's judgment, may compromise the subject's safety or interfere with the conduct and outcome of the study
  • Difficult to be compliant with recalls, such as extensive travel commitments, lack of transportation etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3M Dry Mouth Moisturizing Spray
Dry mouth agent
Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray
20 ml bottle
Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray
44.3 ml bottle
Active Comparator: Biotene Moisturizing Mouth Spray
Dry mouth agent
Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray
20 ml bottle
Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray
44.3 ml bottle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
10 cm Mouth Dryness Visual Analog Score
Time Frame: 15 minutes post dose
Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms.
15 minutes post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
10 cm Mean Mouth Dryness Visual Analog Score
Time Frame: 240 minutes post dose
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
240 minutes post dose
10 cm Mouth Dryness Visual Analog Score
Time Frame: 240 minutes
Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
240 minutes
10 cm Mean Mouth Dryness Visual Analog Score
Time Frame: 5 minutes
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
5 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Time Frame: 30 minutes
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
30 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Time Frame: 60 minutes
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
60 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Time Frame: 120 minutes
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
120 minutes
10 cm Mouth Dryness Visual Analog Scale
Time Frame: 5 minutes
Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
5 minutes
10 cm Mouth Dryness Visual Analog Scale
Time Frame: 15 minutes
Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
15 minutes
10 cm Mouth Dryness Visual Analog Scale
Time Frame: 30 minutes
Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
30 minutes
10 cm Mouth Dryness Visual Analog Score
Time Frame: 60 minutes
Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
60 minutes
10 cm Mouth Dryness Visual Analog Score
Time Frame: 120 minutes
Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
120 minutes
Response on Dry Mouth Relief
Time Frame: 5 minutes
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
5 minutes
Response on Dry Mouth Relief
Time Frame: 15 minutes
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
15 minutes
Response on Dry Mouth Relief
Time Frame: 30 minutes
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
30 minutes
Response on Dry Mouth Relief
Time Frame: 60 minutes
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
60 minutes
Response on Dry Mouth Relief
Time Frame: 120 minutes
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
120 minutes
Response on Dry Mouth Relief
Time Frame: 240 minutes
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
240 minutes
Response to Effectively Lubricates the Mouth
Time Frame: 5 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
5 minutes
Response to Effectively Lubricates the Mouth
Time Frame: 15 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
15 minutes
Response to Effectively Lubricates the Mouth
Time Frame: 30 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
30 minutes
Response to Effectively Lubricates the Mouth
Time Frame: 60 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
60 minutes
Response to Effectively Lubricates the Mouth
Time Frame: 120 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
120 minutes
Response to Effectively Lubricates the Mouth
Time Frame: 240 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
240 minutes
Response to Feel Comfortable in the Mouth
Time Frame: 5 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
5 minutes
Response to Feel Comfortable in the Mouth
Time Frame: 15 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
15 minutes
Response to Feel Comfortable in the Mouth
Time Frame: 30 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
30 minutes
Response to Feel Comfortable in the Mouth
Time Frame: 60 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
60 minutes
Response to Feel Comfortable in the Mouth
Time Frame: 120 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
120 minutes
Response to Feel Comfortable in the Mouth
Time Frame: 240 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
240 minutes
Response to Soothing in the Mouth
Time Frame: 5 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
5 minutes
Response to Soothing in the Mouth
Time Frame: 15 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
15 minutes
Response to Soothing in the Mouth
Time Frame: 30 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
30 minutes
Response to Soothing in the Mouth
Time Frame: 60 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
60 minutes
Response to Soothing in the Mouth
Time Frame: 120 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
120 minutes
Response to Soothing in the Mouth
Time Frame: 240 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
240 minutes
Response to Effectively Moistens the Mouth
Time Frame: 5 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
5 minutes
Response to Effectively Moistens the Mouth
Time Frame: 15 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
15 minutes
Response to Effectively Moistens the Mouth
Time Frame: 30 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
30 minutes
Response to Effectively Moistens the Mouth
Time Frame: 60 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
60 minutes
Response to Effectively Moistens the Mouth
Time Frame: 120 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
120 minutes
Response to Effectively Moistens the Mouth
Time Frame: 240 minutes
5 point ordinal scale 1 = Poor and 5 = Excellent
240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Solventum US LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
3M

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yiming Li, DDS,MSD,PhD, LOMA LINDA UNIVERSITY, School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EM-11-050038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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