Clinical trial NCT05243745: Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth
Official title: An 8-week, Randomised, Controlled, Examiner-Blind, Proof of Principle Study Investigating the Ability of a 3% Methyl Vinyl Ether/Maleic Anhydride Co-Polymer (PVM/MA) + 5% Potassium Nitrate (KNO3) Combination Toothpaste to Protect From Dentine Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: HALEON
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 120
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: This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.

Detailed description: This will be a PoP, single centre, 8-week, randomised, controlled, examiner blind, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth) clinical study in healthy participants with sensitive teeth.

Eligibility criteria: Inclusion Criteria:

* Provision of a signed and dated informed consent indicating the participant has been informed of all pertinent aspects of the study before any study procedures are performed.
* Participant who is willing and able to comply with scheduled visits, product usage requirements 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 or relevant abnormalities in medical history, or upon oral examination, that would impact the participant's safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
* Female participant of child-bearing potential and at risk for pregnancy who agrees to use a highly effective method of contraception throughout the study and for at least 5 days after the last use of assigned study product.
* AT VISIT 1 (Screening):

Participant must have

1. a self-reported history of tooth sensitivity 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 confirmed DH; each tooth must meet the following criteria:

   * exposed dentine due to facial/cervical erosion, abrasion or gingival recession (EAR).
   * MGI score = 0 adjacent to the test area (exposed dentine) only (Lobene et al.,1986)
   * clinical mobility = 0 (Laster et al., 1975)
   * Dentin Hypersensitivity (DH) as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to \<= 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) with DH, as evidenced by qualifying levels of tactile and evaporative (air) sensitivity (tactile threshold less than or equal to \<= 20 g; Schiff sensitivity score \>= 2) at the Screening and Baseline visits.

Note: All teeth which meet the eligibility criteria at Screening (Visit 1) should be assessed by tactile and evaporative (air) stimuli at Baseline (Visit 2).

The examiner will select two 'test teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both Screening and Baseline. Test teeth should not be adjacent to each other and preferably in different quadrants.

Exclusion Criteria:

* Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study 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 of study entry and/or during study participation.
* Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study 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.
* Female participant who is pregnant (as evidenced by a positive urine pregnancy test (UPT) at Screening) or intending to become pregnant during the study.
* Female participant who is breastfeeding.
* Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
* Participant who is unwilling or unable to comply with the Lifestyle Considerations.
* Participant with a recent history (within the last year) of alcohol or other substance abuse.
* Participant who has participated in another tooth sensitivity study within 8 weeks of Screening.
* Participant who has used an oral care product indicated for the relief of DH or care of sensitive teeth within 8 weeks of Screening (participants will be required to verbally confirm the name of their current oral care products to enable site staff to verify the absence of known sensitivity ingredients).
* Participant who has had dental prophylaxis within 4 weeks of Screening.
* Participant who has had a teeth 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.
* Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator, would impact study outcomes.
* Participant with multiple dental implants which, in the opinion of the investigator, would 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 or recent caries or reported treatment of decay within 12 months of Screening.
  2. Tooth with exposed dentine but with deep, defective or facial restorations.
  3. Tooth with full crown or veneer.
  4. Tooth adjacent to a bridge abutment or crown which, in the opinion of the investigator, would impact study outcomes.
  5. Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentine.
  6. Sensitive tooth not expected to benefit from use of a sensitivity toothpaste 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 their perception of tooth sensitivity (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, 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 acclimatisation period.

* Participant who is 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 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 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: Mean Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) at Baseline (Day 0)
timeFrame: Baseline (Day 0)
measure: Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
timeFrame: Day 3
measure: Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
timeFrame: Day 14
measure: Mean Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
timeFrame: Day 28
measure: Mean 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 Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in Tactile Threshold at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in Mean Score of Dentine Hypersensitivity Experience Questionnaire (DHEQ) (Section 1 Questions 7-9) at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in DHEQ Total Score (Section 2 Questions 1-15) at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in DHEQ Restrictions Domain Score (Section 2 Questions 1 to 3) at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28, 56
measure: Change From Baseline in DHEQ Adaptation Domain Score (Section 2 Questions 4 to 6) at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in DHEQ Social Impact Domain Score (Section 2 Questions 7 to 9) at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in DHEQ Emotional Impact Domain Score (Section 2 Questions 10 to 12) at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in DHEQ Identity Domain Score (Section 2 Questions 13 to 15) at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Mean Numeric Rating Scale (NRS) Score at Baseline, Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
measure: Change From Baseline in Mean NRS Score at Days 3, 14, 28 and 56
timeFrame: Baseline (Day 0), Days 3, 14, 28 and 56
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Dental School, University of Bristol
Study officials:
References: