Oral Mucosal DisorderNCT04601103

3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes

A study testing No SLS toothpaste, Medium SLS toothpaste and High SLS toothpaste in people with Oral Mucosal Disorder, run by Solventum US LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Oral Mucosal Disorder
What is being tested?: No SLS toothpaste, Medium SLS toothpaste and High SLS toothpaste
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: 6 Jan 2020to 10 Mar 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 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to understand and willing to sign the informed consent;
Willing to agree to maintain confidentiality of the study and study materials;
3M employee aged 18 years and older;
Willing to return to the study facility for scheduled study visits and recalls;
Agree not to use other oral hygiene products (non-study toothpaste, non-study toothbrush, mouth rinse, chewing gum);
Agree to the study instruction and schedule

Who cannot join

A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;
Have a dental appointment scheduled during study duration for professional cleaning;
Is pregnant, nursing, or planning to become pregnant within the study duration;
History of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (e.g., cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves and prosthetic implants);
History of using a prescription antimicrobial mouth rinse during the past 3 months;
Currently taking medications which may alter gingival appearance/bleeding;

Show all 21Show fewer

Currently using anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health;
Participation in any other clinical study within the last 30 days;
Resides in the same household with a subject already enrolled in the study;
Known history of sensitivity to oral hygiene products;
Currently using tobacco products (cigarettes, chewing tobacco) or vaping products (ecigarettes);
History of diabetes;
Have removable partial/full dentures;
Have orthodontic appliances;
Have medical or oral conditions that may compromise the subject's safety or interfere with the conduct and outcome of the study;
Have known sloughing within the last 3 weeks;
Have dry mouth;
Have widespread caries or chronic neglect;
Have gross pathological changes of oral soft tissues;
Have advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss);
Unsuitable for enrollment in this study based on the professional opinion of the dental examiner based on the oral exam or other reasons not specified in the protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

3M Health Care
Saint Paul, Minnesota, 55144

Other trials in United States

About this study

Official title: 3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.

Read the detailed description

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS).

Determine the subjects' acceptance of sloughing and/or other side effects

Conditions: Oral Mucosal Disorder
Being tested: No SLS toothpaste, Medium SLS toothpaste, High SLS toothpaste, Anti-plaque

What participants receive

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

No SLS toothpasteDrug
Also called Sensodyne ProNamel Fresh Breath Toothpaste
Toothpaste no Sodium Lauryl Sulfate
Medium SLS toothpasteDrug
Also called Clinpro Tooth Creme
Less than or equal to X ppm Sodium Lauryl Sulfate
High SLS toothpasteDrug
Also called Colgate Cavity Protection Toothpaste
More than or equal to X ppm Sodium Lauryl Sulfate
Anti-plaqueDevice
Also called 3M Oral Rinse
Rinse prevents bacterial adherence to teeth

Study groups in NCT04601103
Study group	Role	What they receive
Comparator: No SLS Toothpaste	Experimental	3M Oral Rinse in combination with no SLS toothpaste (A) Receives: Drug: No SLS toothpaste; Device: Anti-plaque
Comparator: Medium SLS Toothpaste	Experimental	3M Oral Rinse in combination with medium SLS toothpaste (B) Receives: Drug: Medium SLS toothpaste; Device: Anti-plaque
Comparator: High SLS Toothpaste	Experimental	3M Oral Rinse in combination with high SLS toothpaste (C) Receives: Drug: High SLS toothpaste; Device: Anti-plaque

What is being measured

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

Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.
Measured: End of treatment (3 weeks)

Secondary outcomes (2)

The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas.
The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue.
(upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Measured: Mid-Treatment (10 days)
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
Average score based on the mean of sloughing scores over 12 intra-oral areas. The sloughing score uses a 6 point scale as follows: 0= no sloughing, 1=flecks of desquamation, 2=sheets of desquamation, 3=redness, not due to plaque, 4=erosion of mucosa, 5=ulcerated areas.
The twelve intra-oral areas of the mouth are as follows: dorsal and ventral surfaces of the tongue, floor and roof of the mouth, right and left buccal mucosa, gingival tissue.
(upper right, upper anterior, upper left, lower left, lower anterior, lower right)
Measured: End of Treatment (3 weeks)

Timeline

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

6 Jan 202010 Mar 2020

First posted23 Oct 2020
Study start6 Jan 2020
Primary completion10 Mar 2020
Study completion10 Mar 2020

Why it stopped: Device Deficiency

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 Oral Mucosal DisorderStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study was designed as an imbalanced 2 Period Crossover Study. However, the study was terminated during the washout period and the results reported here reflect only the period 1 results.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04601103
Sponsor's protocol ID: EM-11-050043
Status last verified: Sep 2024
First submitted: 13 Oct 2020
Last updated: 1 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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 Oral Mucosal Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes
ClinicalTrials.gov ID: NCT04601103
Acronym / sponsor ID: EM-11-050043
Conditions: Oral Mucosal Disorder
Study type: Interventional
Recruitment status: TerminatedReason stopped: Device Deficiency
Enrolment: 53 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: 6 Jan 2020 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 10 Mar 2020 (actual)
First posted: 23 Oct 2020 (actual)
Results: Posted 19 Nov 2021

Clinical summary

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

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.

Detailed description

Determine the subjects' acceptance of sloughing and/or other side effects

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: The study was designed as an imbalanced 2 Period Crossover Study. However, the study was terminated during the washout period and the results reported here reflect only the period 1 results.

Arm	Type	Receives
Comparator: No SLS Toothpaste	Experimental	Drug: No SLS toothpaste, Device: Anti-plaque3M Oral Rinse in combination with no SLS toothpaste (A)
Comparator: Medium SLS Toothpaste	Experimental	Drug: Medium SLS toothpaste, Device: Anti-plaque3M Oral Rinse in combination with medium SLS toothpaste (B)
Comparator: High SLS Toothpaste	Experimental	Drug: High SLS toothpaste, Device: Anti-plaque3M Oral Rinse in combination with high SLS toothpaste (C)

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Able to understand and willing to sign the informed consent;
Willing to agree to maintain confidentiality of the study and study materials;
3M employee aged 18 years and older;
Willing to return to the study facility for scheduled study visits and recalls;
Agree not to use other oral hygiene products (non-study toothpaste, non-study toothbrush, mouth rinse, chewing gum);

Key exclusion criteria (21 listed)

A member of the Medical Clinical Affairs (MCA) staff or Panda product team for the device under investigation;
Have a dental appointment scheduled during study duration for professional cleaning;
Is pregnant, nursing, or planning to become pregnant within the study duration;
History of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (e.g., cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves and prosthetic implants);
History of using a prescription antimicrobial mouth rinse during the past 3 months;

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
No SLS toothpasteAlso: Sensodyne ProNamel Fresh Breath ToothpasteToothpaste no Sodium Lauryl Sulfate	Drug	Comparator: No SLS Toothpaste
Medium SLS toothpasteAlso: Clinpro Tooth CremeLess than or equal to X ppm Sodium Lauryl Sulfate	Drug	Comparator: Medium SLS Toothpaste
High SLS toothpasteAlso: Colgate Cavity Protection ToothpasteMore than or equal to X ppm Sodium Lauryl Sulfate	Drug	Comparator: High SLS Toothpaste
Anti-plaqueAlso: 3M Oral RinseRinse prevents bacterial adherence to teeth	Device	Comparator: High SLS Toothpaste, Comparator: Medium SLS Toothpaste, Comparator: No SLS Toothpaste

Primary outcome

Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)
Time frame: End of treatment (3 weeks)
Percentage of participants who experienced oral sloughing as reported either by the subject or determined by the dental evaluator.

2 secondary outcomes

The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores
Time frame: Mid-Treatment (10 days)
The Number of Participants With a Given Range of Average Oral Mucosal Sloughing Index Scores.
Time frame: End of Treatment (3 weeks)

Results and safety

Results posted to the registry on 19 Nov 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
Comparator: No SLS Toothpaste	18	0
Comparator: Medium SLS Toothpaste	18	0
Comparator: High SLS Toothpaste	17	0

Primary outcome: Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing)

Time frame: End of treatment (3 weeks). Count of participants. Unit: Participants

Measure	Comparator: No SLS Toothpaste n = 18	Comparator: Medium SLS Toothpaste n = 18	Comparator: High SLS Toothpaste n = 17
Value	15	14	13

Comparator: No SLS Toothpaste vs Comparator: Medium SLS Toothpaste vs Comparator: High SLS Toothpaste: p = .916, Fisher Exact

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 3 weeks of starting treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comparator: No SLS Toothpaste	0 of 18 (0%)	15 of 18 (83.3%)	0 of 18
Comparator: Medium SLS Toothpaste	0 of 18 (0%)	15 of 18 (83.3%)	0 of 18
Comparator: High SLS Toothpaste	0 of 17 (0%)	16 of 17 (94.1%)	0 of 17

Limitations and caveats (from the sponsor): The major limitation with this study is that the sample size goal was not reached given the early termination during the washout period of a two-period crossover design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Oral Mucosal Disorder

RecruitingObservational study
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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.

Brenda C Coalwell, BA principal investigator

3M Health Care Business Group

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

Questions about this trial

What is this clinical trial studying?

A study testing No SLS toothpaste, Medium SLS toothpaste and High SLS toothpaste in people with Oral Mucosal Disorder, run by Solventum US LLC 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 6 inclusion and 21 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: stopped early, as of the sponsor's last update on 1 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 19 Nov 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?

Number of Participants With Oral Mucosal Exfoliation (Oral Sloughing) (time frame: End of treatment (3 weeks)). 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 NCT04601103.

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 1 Oct 2024.