Clinical trial NCT03943095: Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity
Official title: Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentin Hypersensitivity
Dentin Sensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, 8-week, randomized, controlled, parallel design, exploratory clinical study in healthy participants with dentin hypersensitivity. Eligible participants will be stratified by the maximum Baseline Schiff sensitivity score of their two selected test teeth).
Primary purpose: TREATMENT

Brief summary: This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.

Detailed description: This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth), Phase II, exploratory clinical study in healthy participants with DH. It is hypothesized that the combination of two antisensitivity active ingredients with complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride: dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either active alone.

Eligibility criteria: Inclusion Criteria:

* Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
* Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures
* Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history, or upon oral examination, or condition that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements
* Male participant able to father children or female participant of child-bearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment
* AT VISIT 1 (Screening): Participant must have

  1. a self-reported history of dentin hypersensitivity (DH) lasting more than six months but not more than 10 years
  2. a minimum of 20 natural teeth
  3. a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically diagnosed DH; each tooth must meet the following criteria:
* exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR)
* Modified Gingival Index (MGI) score = 0 adjacent to the test area (exposed dentin) only
* Clinical mobility less than or equal to (=\<) 1
* DH, as evidenced by qualifying levels of tactile and evaporative air sensitivity (tactile threshold \[=\<\] 20 gram (g); Schiff sensitivity score greater than or equal to \[\>=\] 2)
* AT VISIT 2 (Baseline):

Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with DH, as evidenced by qualifying tactile and evaporative air sensitivity (each tooth must have a tactile threshold (=\<) 20 g and a Schiff sensitivity score (\>=) 2) at the Screening and Baseline visits

Exclusion Criteria:

* Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family
* Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation
* Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, oral, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study
* Participant with any condition which, in the opinion of the investigator or medically qualified designee, causes xerostomia
* Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test \[UPT\] at Screening)
* Participant who is a breast-feeding female
* Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
* Participant with a recent history (within the last year) of alcohol or other substance abuse
* Participant who has participated in another tooth desensitizing treatment study within 8 weeks Screening
* Participant who has used an oral care product indicated for the relief of DH within 8 weeks of Screening (participant will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
* Participant who has had dental prophylaxis within 4 weeks of Screening
* Participant who has had a tooth bleaching procedure within 8 weeks of Screening
* Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening
* Participant who has had scaling or root planning within 3 months of Screening
* Participant with gross periodontal disease
* Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy
* Participant with a tongue or lip piercing or presence of multiple dental implants
* Participant with fixed or removable partial dentures
* 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 or recent caries or reported treatment of decay within 12 months of Screening
  2. Tooth with exposed dentin but with deep, defective or facial restorations
  3. Tooth with full crown or veneer
  4. Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentin
  5. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
* Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with the perception of pain (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs)
* AT VISIT 1 (Screening):

Participant who has taken antibiotics in the 2 weeks prior to the Screening visit

- AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatization period

* Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia
* Participant who requires antibiotic prophylaxis for dental procedures
* Participant who 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: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3
timeFrame: Day 3
measure: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7
timeFrame: Day 7
measure: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14
timeFrame: Day 14
measure: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28
timeFrame: Day 28
measure: Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56
timeFrame: Day 56
measure: Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3
timeFrame: Day 3
measure: Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7
timeFrame: Day 7
measure: Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14
timeFrame: Day 14
measure: Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28
timeFrame: Day 28
measure: Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56
timeFrame: Day 56
measure: Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
timeFrame: Baseline (Day 0)
measure: Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
timeFrame: Day 3
measure: Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7
timeFrame: Day 7
measure: Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
timeFrame: Day 14
measure: Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
timeFrame: Day 28
measure: Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
timeFrame: Day 56
Secondary outcomes:
measure: Change From Baseline in Schiff Sensitivity Score at Day 56
timeFrame: Baseline (Day 0), Day 56
measure: Change From Baseline (Day 0) in Tactile Threshold on Day 56
timeFrame: Baseline (Day 0), Day 56
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: