Dentin HypersensitivityNCT05768373
A Comparison Study of Hypersensitivity Treatment
A study testing 3M™ Clinpro™ Fluoride Aqueous Solution and 3M™ Vanish™ in people with Dentin Hypersensitivity, run by Solventum US LLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the effect of 3M™ Clinpro™ Fluoride Aqueous Solution (experimental) on Dentin Hypersensitivity (DHS) in comparison to 3M™ Vanish™ (commercialized, control] in patients who have DHS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- 3M™ Clinpro™ Fluoride Aqueous Solution and 3M™ Vanish™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 14 Jul 2023
- 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
- Subject has at least one affected hypersensitive tooth upon air blast stimuli in the cervical area, and baseline pain score of 40 mm and above as assessed by the 100 mm VAS.
- Subject is at least 18 years old and have a minimum of 20 natural teeth.
- Subject is willing to withhold desensitizing treatment, including prescription, in-office or over the counter (OTC) desensitizing products, throughout the study period AND withhold during the washout period.
- Subject agrees to only use the provided toothpaste, toothbrush, and follows all oral hygiene instructions throughout the study period AND follows all oral hygiene instructions during the washout period.
- Subject is able to understand and willing to sign the Informed Consent, and is willing to return to the study facility for scheduled study visits and recalls.
Who cannot join
- Subject has medical (including psychiatric) and pharmacotherapeutic histories that may compromise the protocol - including the chronic use of anti-inflammatory, analgesic (pain), and mind-altering drugs; or analgesic (pain) medications within 48 hours prior to application of treatment.
- Subject is pregnant (self-reported) or breast feeding.
- Subject has allergies to product ingredients, eg, rosin, mint flavoring.
- Subject has systemic conditions that are etiologic or predisposing to dentin hypersensitivity (eg, chronic acid regurgitation).
- Subject has excessive dietary or environmental exposure to acids at time of screening.
- Subject had periodontal treatment, bleaching treatments, or orthodontic treatments within previous 3 months or plans to have any other dental treatments during the study period.
Show all 15Show fewer
- Subject is enrolled in another clinical trial at the time of screening that would interfere with this study.
- Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria.
- Individual teeth may not be included that meet any of the following criteria:
- Study tooth has periodontal probing depth of ≥ 4 mm.
- Study tooth or the surrounding supporting tissue has any other painful pathology or defects.
- Study tooth has been restored in the preceding 3 months.
- Study tooth is an abutment for fixed or removable prostheses or suffers traumatic malocclusion.
- Study tooth is crowned or extensively restored and the restorations extending into the test area.
- The tooth has dentin hypersensitivity due to cracked enamel.
Trial locations and contacts
1 site in 1 country.
United States1 site
LOMA LINDA UNIVERSITY, School of Dentistry
Loma Linda, California, 92350
About this study
Official title: Clinical Evaluation of Clinpro™ 2.1% Sodium Fluoride Aqueous Solution in the Treatment of Dentin Hypersensitivity
The goal of this clinical trial is to evaluate the effect of 3M™ Clinpro™ Fluoride Aqueous Solution (experimental) on Dentin Hypersensitivity (DHS) in comparison to 3M™ Vanish™ (commercialized, control] in patients who have DHS.
Participants will be asked to complete the following activities:
Read more
Undergo a pre-treatment washout period for 3- to 6-weeks (± 4 days) post-enrollment. During this time, the Subject is to only use the provided oral hygiene products.
Hypersensitivity will be assessed prior to (baseline) and immediately after sample application.
Subject will be asked to come to the facility for hypersensitivity assessments at 24 hours, 7 days, and 30 days after the treatment visit.
Researchers will compare 3M™ Clinpro™ Fluoride Aqueous Solution to 3M™ Vanish™ to evaluate if the effect of Clinpro™ on DHS treatment is non-inferior to Vanish™.
Read the detailed description
After Informed Consent has been obtained, the subjects will be given study supplied oral hygiene products (e.g., toothbrush and toothpaste) to be used immediately after the consent visit and throughout the entire duration of the study.
Subjects will have a minimum wash-out period of 3 weeks followed by 1 treatment visit. At the treatment visit, a pain assessment will be performed (ie, a baseline pain score) in response to both an air-blast stimulus and tactile stimulus. After each stimulus, the Subject should score their pain using a Visual Analog Scale (VAS).
After recording baseline pain scores, Clinpro™ (Treatment arm) or Vanish™ (Control arm) will be applied according to the manufacturer's IFU. Pain in response to air blast and probe test will be assessed using VAS immediately after application of fluoride treatment (within 15 minutes). Pain response will be assessed again at 24 h, 7 d, 21 d and 30 d post-application of the treatment.
- Conditions
- Dentin Hypersensitivity
- Being tested
- 3M™ Clinpro™ Fluoride Aqueous Solution, 3M™ Vanish™
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Clinpro™ Fluoride Aqueous SolutionDevice
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
3M™ Vanish™Device
Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | Experimental | Investigational product. Receives: Device: 3M™ Clinpro™ Fluoride Aqueous Solution |
| 3M™ Vanish™ | Active comparator | Commercialized product Receives: Device: 3M™ Vanish™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain From Baseline Immediately After Application of Test Product.
Change in sensitivity as assessed using a Visual Analog Scale (VAS, 0 - 100 mm) immediately after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Measured: Base line and immediately after application (within 15 minutes post-treatment).
Change in Pain From Baseline 24 Hours Post Application of Test Product.
This is a co-primary endpoint
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 24 hours after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Measured: Baseline and 24 hours post-treatment
Secondary outcomes (3)
Change in Pain From Baseline 7 Days Post Application of Test Product.
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 7 days after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Measured: Baseline and 7 days post-treatment
Change in Pain From Baseline 21 Days Post Application of Test Product.
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 21 days after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Measured: Baseline and 21 days post-treatment
Change in Pain From Baseline 30 Days Post Application of Test Product.
Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 30 days after exposure to air stimulus relative to baseline.
The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Measured: Baseline and 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start4 Apr 2023
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
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 Dentin HypersensitivityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yiming Li, Principal investigator, Loma Linda University, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768373
- Sponsor's protocol ID
- EM-11-050084
- Status last verified
- Jan 2025
- First submitted
- 1 Mar 2023
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Clinpro™ 2.1% Sodium Fluoride Aqueous Solution in the Treatment of Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT05768373
- Acronym / sponsor ID
- EM-11-050084
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the effect of 3M™ Clinpro™ Fluoride Aqueous Solution (experimental) on Dentin Hypersensitivity (DHS) in comparison to 3M™ Vanish™ (commercialized, control] in patients who have DHS.
Participants will be asked to complete the following activities:
Undergo a pre-treatment washout period for 3- to 6-weeks (± 4 days) post-enrollment. During this time, the Subject is to only use the provided oral hygiene products.
Hypersensitivity will be assessed prior to (baseline) and immediately after sample application.
Subject will be asked to come to the facility for hypersensitivity assessments at 24 hours, 7 days, and 30 days after the treatment visit.
Researchers will compare 3M™ Clinpro™ Fluoride Aqueous Solution to 3M™ Vanish™ to evaluate if the effect of Clinpro™ on DHS treatment is non-inferior to Vanish™.
Detailed description
After Informed Consent has been obtained, the subjects will be given study supplied oral hygiene products (e.g., toothbrush and toothpaste) to be used immediately after the consent visit and throughout the entire duration of the study.
Subjects will have a minimum wash-out period of 3 weeks followed by 1 treatment visit. At the treatment visit, a pain assessment will be performed (ie, a baseline pain score) in response to both an air-blast stimulus and tactile stimulus. After each stimulus, the Subject should score their pain using a Visual Analog Scale (VAS).
After recording baseline pain scores, Clinpro™ (Treatment arm) or Vanish™ (Control arm) will be applied according to the manufacturer's IFU. Pain in response to air blast and probe test will be assessed using VAS immediately after application of fluoride treatment (within 15 minutes). Pain response will be assessed again at 24 h, 7 d, 21 d and 30 d post-application of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M™ Clinpro™ Fluoride Aqueous Solution | Experimental | Device: 3M™ Clinpro™ Fluoride Aqueous SolutionInvestigational product. |
| 3M™ Vanish™ | Active comparator | Device: 3M™ Vanish™Commercialized product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has at least one affected hypersensitive tooth upon air blast stimuli in the cervical area, and baseline pain score of 40 mm and above as assessed by the 100 mm VAS.
- Subject is at least 18 years old and have a minimum of 20 natural teeth.
- Subject is willing to withhold desensitizing treatment, including prescription, in-office or over the counter (OTC) desensitizing products, throughout the study period AND withhold during the washout period.
- Subject agrees to only use the provided toothpaste, toothbrush, and follows all oral hygiene instructions throughout the study period AND follows all oral hygiene instructions during the washout period.
- Subject is able to understand and willing to sign the Informed Consent, and is willing to return to the study facility for scheduled study visits and recalls.
Key exclusion criteria (15 listed)
- Subject has medical (including psychiatric) and pharmacotherapeutic histories that may compromise the protocol - including the chronic use of anti-inflammatory, analgesic (pain), and mind-altering drugs; or analgesic (pain) medications within 48 hours prior to application of treatment.
- Subject is pregnant (self-reported) or breast feeding.
- Subject has allergies to product ingredients, eg, rosin, mint flavoring.
- Subject has systemic conditions that are etiologic or predisposing to dentin hypersensitivity (eg, chronic acid regurgitation).
- Subject has excessive dietary or environmental exposure to acids at time of screening.
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™ Clinpro™ Fluoride Aqueous SolutionHypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity. | Device | 3M™ Clinpro™ Fluoride Aqueous Solution |
| 3M™ Vanish™Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity. | Device | 3M™ Vanish™ |
Primary outcome
Change in Pain From Baseline Immediately After Application of Test Product.
Time frame: Base line and immediately after application (within 15 minutes post-treatment).
Change in sensitivity as assessed using a Visual Analog Scale (VAS, 0 - 100 mm) immediately after exposure to air stimulus relative to baseline. The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
Change in Pain From Baseline 24 Hours Post Application of Test Product.
Time frame: Baseline and 24 hours post-treatment
This is a co-primary endpoint Change in sensitivity as assessed using 100-mm Visual Analog Score (VAS) 24 hours after exposure to air stimulus relative to baseline. The VAS consists of a 100mm line, with two extremes being 0 mm (no pain) and 100 mm (worst pain). Higher scores mean a worse outcome.
3 secondary outcomes
Change in Pain From Baseline 7 Days Post Application of Test Product.
Time frame: Baseline and 7 days post-treatment
Change in Pain From Baseline 21 Days Post Application of Test Product.
Time frame: Baseline and 21 days post-treatment
Change in Pain From Baseline 30 Days Post Application of Test Product.
Time frame: Baseline and 30 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- 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.
Yiming Li 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?
A study testing 3M™ Clinpro™ Fluoride Aqueous Solution and 3M™ Vanish™ in people with Dentin Hypersensitivity, 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 5 inclusion and 15 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 7 Feb 2025. 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 7 Feb 2025). 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?
Change in Pain From Baseline Immediately After Application of Test Product. (time frame: Base line and immediately after application (within 15 minutes post-treatment).). 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?
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 7 Feb 2025.