Clinical trial NCT06359028: Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers
Official title: An 8-Week, Randomized, Controlled, Examiner-Blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentin Hypersensitivity in a Population of Dentin Hypersensitivity Sufferers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste.

Detailed description: This will be a single center, 8-week, randomized, controlled, examiner-blind, 2-treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected 'test teeth') clinical study to evaluate the anti-sensitivity efficacy of a 0.454% SnF2 toothpaste in a DH population. The clinical efficacy of the 0.454% SnF2 toothpaste (test toothpaste) will be compared with that of a reference toothpaste, a commercially available, regular fluoride toothpaste with no known anti-sensitivity properties (negative control). Sufficient participants will be screened to randomize approximately 110 participants to investigational product (approximately 55 per treatment group) and to ensure approximately 100 evaluable participants complete the entire study (approximately 50 per treatment group).

Eligibility criteria: Inclusion Criteria:

* Participant provision of signed and dated informed consent before any study procedures are performed.
* Participant is male or female.
* Participant is 18 to 65 years of age, inclusive, at the time of signing the informed consent.
* Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
* Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
* Screening (Visit 1): Participant must have-

  1. History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
  2. Good general oral health, with a minimum of 20 natural teeth.
  3. Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria:

     1. Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR).
     2. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only).
     3. Clinical mobility = 0
     4. Clinically confirmed DH to both tactile and evaporative (air) stimuli: a) Qualifying tactile threshold less than or equal to (\<=) 20g. b) Qualifying Schiff sensitivity score more than or equal to (\>=) 2.
* Baseline (Visit 2, Pre-Treatment)

  1. Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), in different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both screening (Visit 1) and baseline (Visit 2).

     1. Qualifying tactile threshold \<= 20g at screening and baseline.
     2. Qualifying Schiff sensitivity score \>= 2 at screening and baseline.
  2. The clinical examiner will select two 'Test Teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both screening and baseline. Notes: All teeth with clinically confirmed, qualifying levels of DH at screening (that is, a screening tactile threshold \<= 20 g and a screening Schiff sensitivity score \>= 2) will be assessed for tactile sensitivity at baseline. Teeth with a baseline tactile threshold \<= 20g will then be assessed for baseline evaporative (air) sensitivity.

Exclusion Criteria:

* Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
* Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
* Female participant who is pregnant or intending to become pregnant during the study (self-reported).
* Female participant who is breastfeeding (self-reported).
* Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
* Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
* Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
* Participant has participated in a tooth sensitivity study within 8 weeks of screening (Visit 1).
* Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-sensitivity product within 8 weeks of screening (Visit 1). Participants will be required to bring their current oral care products to screening (Visit 1) for staff to verify the absence of known anti-sensitivity ingredients and sensitivity-related claims on the product packaging/label text.
* Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
* Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior to screening (Visit 1).
* Baseline (Visit 2, Pre-Treatment): Participant has taken antibiotics in the 2 weeks prior to baseline (Visit 2), that is, during the acclimatization period.
* Participant takes daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
* Participant requires antibiotic prophylaxis for dental procedures.
* Participant has had professional tooth de-sensitising treatment within 8 weeks of screening (Visit 1).
* Participant has had a tooth bleaching procedure within 8 weeks of screening (Visit 1).
* Participant has had dental prophylaxis within 4 weeks of screening (Visit 1).
* Participant has had treatment for periodontal disease (including surgery) within 12 months of screening (Visit 1).
* Participant has had scaling or root planning within 3 months of screening (Visit 1).
* Participant with gross periodontal disease.
* Participant with a tongue or lip piercing.
* Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy.
* Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
* Participant with multiple dental implants which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
* Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
* Specific dentition exclusions for 'Test Teeth':

  1. Tooth with evidence of current/recent caries.
  2. Tooth with (self-reported) treatment for decay within 12 months of screening (Visit 1).
  3. Tooth with exposed dentin and deep, defective or facial restorations.
  4. Tooth with a full crown or veneer.
  5. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
  6. Sensitive tooth with contributing etiologies other than EAR to exposed dentin.
  7. Sensitive tooth not expected to benefit from use of an anti-sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.
* Participant who, in the opinion of the investigator or designee, is unable to provide appropriate responses to the Labelled Magnitude Scale (LMS) training questions.
* Participant has previously been enrolled in this study.
* Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Primary outcomes:
measure: Change from Baseline in Schiff Sensitivity Score at Day 56
timeFrame: Baseline and Day 56
Secondary outcomes:
measure: Change from Baseline in Tactile Threshold at Day 56
timeFrame: Baseline and Day 56
measure: Change from Baseline in Schiff sensitivity score at Day 28
timeFrame: Baseline and Day 28
measure: Change from Baseline in Tactile Threshold at Day 28
timeFrame: Baseline and Day 28
measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56
timeFrame: Baseline, Day 28 and Day 56
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
References: