XerostomiaNCT04186806

Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

A study testing 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray and Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray in people with Xerostomia, run by Solventum US LLC at 1 site in United States.

Completed

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

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Xerostomia
What is being tested?: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray and Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2019to 13 Dec 2019
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
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 29Show fewer

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University, School of Dentistry
Loma Linda, California, 92350

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Xerostomia
Being tested: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray, Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray
Medical subject headings: Xerostomia

What participants receive

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

3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth SprayDevice
20 ml bottle
Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing SprayDevice
44.3 ml bottle

Study groups in NCT04186806
Study group	Role	What they receive
3M Dry Mouth Moisturizing Spray	Experimental	Dry mouth agent Receives: Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray; Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray
Biotene Moisturizing Mouth Spray	Active comparator	Dry mouth agent Receives: Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray; Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

What is being measured

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

10 cm Mouth Dryness Visual Analog Score
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.
Measured: 15 minutes post dose

Secondary outcomes (41)

10 cm Mean Mouth Dryness Visual Analog Score
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
Measured: 240 minutes post dose
10 cm Mouth Dryness Visual Analog Score
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.
Measured: 240 minutes
10 cm Mean Mouth Dryness Visual Analog Score
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
Measured: 5 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
Measured: 30 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
Measured: 60 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms
Measured: 120 minutes
10 cm Mouth Dryness Visual Analog Scale
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.
Measured: 5 minutes
10 cm Mouth Dryness Visual Analog Scale
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.
Measured: 15 minutes
10 cm Mouth Dryness Visual Analog Scale
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.
Measured: 30 minutes
10 cm Mouth Dryness Visual Analog Score
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.
Measured: 60 minutes
10 cm Mouth Dryness Visual Analog Score
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.
Measured: 120 minutes
Response on Dry Mouth Relief
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
Measured: 5 minutes
Response on Dry Mouth Relief
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
Measured: 15 minutes
Response on Dry Mouth Relief
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
Measured: 30 minutes
Response on Dry Mouth Relief
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
Measured: 60 minutes
Response on Dry Mouth Relief
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
Measured: 120 minutes
Response on Dry Mouth Relief
Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent
Measured: 240 minutes
Response to Effectively Lubricates the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 5 minutes
Response to Effectively Lubricates the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 15 minutes
Response to Effectively Lubricates the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 30 minutes
Response to Effectively Lubricates the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 60 minutes
Response to Effectively Lubricates the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 120 minutes
Response to Effectively Lubricates the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 240 minutes
Response to Feel Comfortable in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 5 minutes
Response to Feel Comfortable in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 15 minutes
Response to Feel Comfortable in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 30 minutes
Response to Feel Comfortable in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 60 minutes
Response to Feel Comfortable in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 120 minutes
Response to Feel Comfortable in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 240 minutes
Response to Soothing in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 5 minutes
Response to Soothing in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 15 minutes
Response to Soothing in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 30 minutes
Response to Soothing in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 60 minutes
Response to Soothing in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 120 minutes
Response to Soothing in the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 240 minutes
Response to Effectively Moistens the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 5 minutes
Response to Effectively Moistens the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 15 minutes
Response to Effectively Moistens the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 30 minutes
Response to Effectively Moistens the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 60 minutes
Response to Effectively Moistens the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 120 minutes
Response to Effectively Moistens the Mouth
5 point ordinal scale 1 = Poor and 5 = Excellent
Measured: 240 minutes

Timeline

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

2 Nov 201913 Dec 2019

First posted5 Dec 2019
Study start2 Nov 2019
Primary completion13 Dec 2019
Study completion13 Dec 2019

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for XerostomiaStudies 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: Crossover
Model description: All subjects completing the wash-in procedures and meeting inclusion/exclusion criteria will undergo a pre-study 5-hour visit (the day before randomization) to assess the effect of water on their dry mouth symptoms. The subjects will return the next day for confirmation that inclusion/exclusion criteria and the wash-in procedures continue to be met or followed. Eligible subjects will be randomized at this baseline visit in a 1:1 ratio to one of two treatment orders: A-\>B (AB) or B-\>A (BA).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04186806
Sponsor's protocol ID: EM-11-050038
Status last verified: Sep 2024
First submitted: 8 Oct 2019
Last updated: 2 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Locker D. Xerostomia in older adults: a longitudinal study. Gerodontology. 1995 Jul;12(1):18-25. doi: 10.1111/j.1741-2358.1995.tb00125.x.
PubMed 8626175
Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
PubMed 9344281
Guijarro Guijarro B, Lopez Sanchez AF, Hernandez Vallejo G. Treatment of xerostomia. A review. Med Oral. 2001 Jan-Feb;6(1):7-18. English, Spanish.
PubMed 11488135
Fontana M, Zunt S, Eckert GJ, Zero D. A screening test for unstimulated salivary flow measurement. Oper Dent. 2005 Jan-Feb;30(1):3-8.
PubMed 15765951
Andersson G, Johansson G, Attstrom R, Edwardsson S, Glantz PO, Larsson K. Comparison of the effect of the linseed extract Salinum and a methyl cellulose preparation on the symptoms of dry mouth. Gerodontology. 1995 Jul;12(1):12-7. doi: 10.1111/j.1741-2358.1995.tb00124.x.
PubMed 8626174

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 Xerostomia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray on the Relief of Dry Mouth Symptoms
ClinicalTrials.gov ID: NCT04186806
Acronym / sponsor ID: EM-11-050038
Conditions: Xerostomia
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: 2 Nov 2019 (actual)
Primary completion: 13 Dec 2019 (actual)
Study completion: 13 Dec 2019 (actual)
First posted: 5 Dec 2019 (actual)
Results: Posted 20 Nov 2020

Clinical summary

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

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: All subjects completing the wash-in procedures and meeting inclusion/exclusion criteria will undergo a pre-study 5-hour visit (the day before randomization) to assess the effect of water on their dry mouth symptoms. The subjects will return the next day for confirmation that inclusion/exclusion criteria and the wash-in procedures continue to be met or followed. Eligible subjects will be randomized at this baseline visit in a 1:1 ratio to one of two treatment orders: A->B (AB) or B->A (BA).

Arm	Type	Receives
3M Dry Mouth Moisturizing Spray	Experimental	Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray, Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing SprayDry mouth agent
Biotene Moisturizing Mouth Spray	Active comparator	Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray, Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing SprayDry mouth agent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

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

Key exclusion criteria (7 listed)

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)

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
3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray20 ml bottle	Device	3M Dry Mouth Moisturizing Spray, Biotene Moisturizing Mouth Spray
Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray44.3 ml bottle	Device	3M Dry Mouth Moisturizing Spray, Biotene Moisturizing Mouth Spray

Primary outcome

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.

41 secondary outcomes

10 cm Mean Mouth Dryness Visual Analog Score
Time frame: 240 minutes post dose
10 cm Mouth Dryness Visual Analog Score
Time frame: 240 minutes
10 cm Mean Mouth Dryness Visual Analog Score
Time frame: 5 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Time frame: 30 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Time frame: 60 minutes
10 cm Mean Mouth Dryness Visual Analog Scale
Time frame: 120 minutes
10 cm Mouth Dryness Visual Analog Scale
Time frame: 5 minutes
10 cm Mouth Dryness Visual Analog Scale
Time frame: 15 minutes
10 cm Mouth Dryness Visual Analog Scale
Time frame: 30 minutes
10 cm Mouth Dryness Visual Analog Score
Time frame: 60 minutes
10 cm Mouth Dryness Visual Analog Score
Time frame: 120 minutes
Response on Dry Mouth Relief
Time frame: 5 minutes
Response on Dry Mouth Relief
Time frame: 15 minutes
Response on Dry Mouth Relief
Time frame: 30 minutes
Response on Dry Mouth Relief
Time frame: 60 minutes
Response on Dry Mouth Relief
Time frame: 120 minutes
Response on Dry Mouth Relief
Time frame: 240 minutes
Response to Effectively Lubricates the Mouth
Time frame: 5 minutes
Response to Effectively Lubricates the Mouth
Time frame: 15 minutes
Response to Effectively Lubricates the Mouth
Time frame: 30 minutes
Response to Effectively Lubricates the Mouth
Time frame: 60 minutes
Response to Effectively Lubricates the Mouth
Time frame: 120 minutes
Response to Effectively Lubricates the Mouth
Time frame: 240 minutes
Response to Feel Comfortable in the Mouth
Time frame: 5 minutes
Response to Feel Comfortable in the Mouth
Time frame: 15 minutes
Response to Feel Comfortable in the Mouth
Time frame: 30 minutes
Response to Feel Comfortable in the Mouth
Time frame: 60 minutes
Response to Feel Comfortable in the Mouth
Time frame: 120 minutes
Response to Feel Comfortable in the Mouth
Time frame: 240 minutes
Response to Soothing in the Mouth
Time frame: 5 minutes
Response to Soothing in the Mouth
Time frame: 15 minutes
Response to Soothing in the Mouth
Time frame: 30 minutes
Response to Soothing in the Mouth
Time frame: 60 minutes
Response to Soothing in the Mouth
Time frame: 120 minutes
Response to Soothing in the Mouth
Time frame: 240 minutes
Response to Effectively Moistens the Mouth
Time frame: 5 minutes
Response to Effectively Moistens the Mouth
Time frame: 15 minutes
Response to Effectively Moistens the Mouth
Time frame: 30 minutes
Response to Effectively Moistens the Mouth
Time frame: 60 minutes
Response to Effectively Moistens the Mouth
Time frame: 120 minutes

Results and safety

Results posted to the registry on 20 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3M Dry Mouth Moisturizing Spray Then Biotene Moisturizing Mouth Spray	20	19
Biotene Moisturizing Mouth Spray Then 3M Dry Mouth Moisturizing Spray	20	20

Primary outcome: 10 cm Mouth Dryness Visual Analog Score

Time frame: 15 minutes post dose. Mean (Standard Deviation). Unit: cm

Measure	3M(TM) Dry Mouth Moisturizing Spray n = 40	Biotene Moisturizing Mouth Spray n = 40
Value	4.51 (2.228)	4.6 (2.604)

3M(TM) Dry Mouth Moisturizing Spray vs Biotene Moisturizing Mouth Spray: Mean Difference (Final Values): -0.3426 (95% CI -1.2601 to 0.5749), Mixed Models Analysis

Population analysed: Intent to treat (ITT) with Group Means Imputation

41 secondary outcomes are reported in the full results.

Adverse events

Time frame: For the entire 7 day treatment period for each study arm. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3M(TM) Dry Mouth Moisturizing Spray	1 of 40 (2.5%)	7 of 40 (17.5%)	0 of 40
Biotene Moisturizing Mouth Spray	0 of 39 (0%)	7 of 39 (17.9%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8626175Locker D. Xerostomia in older adults: a longitudinal study. Gerodontology. 1995 Jul;12(1):18-25. doi: 10.1111/j.1741-2358.1995.tb00125.x.
Background: PubMed 9344281Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
Background: PubMed 11488135Guijarro Guijarro B, Lopez Sanchez AF, Hernandez Vallejo G. Treatment of xerostomia. A review. Med Oral. 2001 Jan-Feb;6(1):7-18. English, Spanish.
Background: PubMed 15765951Fontana M, Zunt S, Eckert GJ, Zero D. A screening test for unstimulated salivary flow measurement. Oper Dent. 2005 Jan-Feb;30(1):3-8.
Background: PubMed 8626174Andersson G, Johansson G, Attstrom R, Edwardsson S, Glantz PO, Larsson K. Comparison of the effect of the linseed extract Salinum and a methyl cellulose preparation on the symptoms of dry mouth. Gerodontology. 1995 Jul;12(1):12-7. doi: 10.1111/j.1741-2358.1995.tb00124.x.
Individual participant dataSharing planned: No

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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.

Yiming Li, DDS,MSD,PhD principal investigator

Loma Linda University, School of Dentistry

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

Questions about this trial

What is this clinical trial studying?

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 29 inclusion and 7 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 2 Oct 2024. 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. 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 20 Nov 2020). 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?

10 cm Mouth Dryness Visual Analog Score (time frame: 15 minutes post dose). 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 NCT04186806, which also lists 5 linked publications.

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 2 Oct 2024.