A Comparison Study of Hypersensitivity Treatment

NCT ID: NCT05768373

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2023-07-14

Brief 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.

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.

Conditions

Dentin Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3M™ Clinpro™ Fluoride Aqueous Solution

Investigational product.

Group Type: EXPERIMENTAL

3M™ Clinpro™ Fluoride Aqueous Solution

Intervention Type: DEVICE

Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.

3M™ Vanish™

Commercialized product

Group Type: ACTIVE_COMPARATOR

3M™ Vanish™

Intervention Type: DEVICE

Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.

Interventions

3M™ Clinpro™ Fluoride Aqueous Solution

Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.

Intervention Type: DEVICE

3M™ Vanish™

Hypersensitivity treatment. Apply once after baseline measurement of dentin sensitivity.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Subject is at least 18 years old and have a minimum of 20 natural teeth.

3. 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.

4. 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.

5. 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.

Exclusion Criteria

1. 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.

2. Subject is pregnant (self-reported) or breast feeding.

3. Subject has allergies to product ingredients, eg, rosin, mint flavoring.

4. Subject has systemic conditions that are etiologic or predisposing to dentin hypersensitivity (eg, chronic acid regurgitation).

5. Subject has excessive dietary or environmental exposure to acids at time of screening.

6. 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.

7. Subject is enrolled in another clinical trial at the time of screening that would interfere with this study.

Individual teeth may not be included that meet any of the following criteria:

9. Study tooth has periodontal probing depth of ≥ 4 mm.

10. Study tooth or the surrounding supporting tissue has any other painful pathology or defects.

11. Study tooth has been restored in the preceding 3 months.

12. Study tooth is an abutment for fixed or removable prostheses or suffers traumatic malocclusion.

13. Study tooth is crowned or extensively restored and the restorations extending into the test area.

14. The tooth has dentin hypersensitivity due to cracked enamel.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Solventum US LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yiming Li

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University, School of Dentistry

Locations

LOMA LINDA UNIVERSITY, School of Dentistry

Loma Linda, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EM-11-050084

Identifier Type: -

Identifier Source: org_study_id