To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH)

This was a single-centre, randomized-controlled, examiner-blind, two treatment group (test
and no treatment), parallel design, stratified (by maximum baseline Schiff sensitivity score
of the two selected test teeth) study, in healthy participants with at least two sensitive
teeth that meet all the criteria at the screening and the baseline pre-treatment visit.
Participants were screened for study suitability at screening visit (Visit 1). At Visit 2
(baseline; pre-treatment) 2 non-adjacent accessible teeth (incisors, canines, premolars) in
different quadrants of the mouth and separated by at least 2 teeth (or equivalent edentulous
space) were identified that demonstrated signs of sensitivity as measured by a qualifying
tactile stimulus (Yeaple ≤ 20 gram [g]) and evaporative air assessment (Schiff sensitivity
score ≥ 2) on the facial/cervical (ie, labial/buccal) tooth surface. Once the 2 test teeth
were selected, the subjects were stratified (by maximum baseline Schiff sensitivity score of
the 2 selected test teeth) and randomized to treatment or no treatment. DH was assessed at
baseline (pre-treatment), and 10mins, 2 & 4 hours post-treatment.

Inclusion Criteria:

- Demonstrates understanding of the study procedures, restrictions and willingness to
participate as evidenced by voluntary written informed consent and has received
assigned and dated copy of the informed consent form.

- Aged 18-65 years.

- Good general and mental health with, in the opinion of the investigator or medically
qualified designee: No clinically significant and relevant abnormalities of medical
history or oral Examination and absence of any condition that would impact on the
participants safety or wellbeing or affect the individual's ability to understand and
follow study procedures and requirements.

- Understands and is willing, able and likely to comply with all study procedures and
restrictions.

- At Visit 1 (Screening): a) Self-reported history of dentinal hypersensitivity (DH)
lasting more than six months but not more than 10 years. b) Minimum of 20 natural
teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars),
in different quadrants and separated by at least two teeth (or equivalent edentulous
space), that meet all of the following criteria: Signs of facial/ cervical (i.e.
labial/ buccal) gingival recession and/or signs of erosion or abrasion (EAR), tooth
with MGI score = 0 adjacent to the test area (exposed dentine) only and a clinical
mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative
air assessment (Y/N response) on the facial/ cervical (i.e. labial/ buccal) tooth
surface.

- At Visit 2, Baseline (Pre-treatment): Minimum of two, non-adjacent accessible teeth
(incisors, canines, pre-molars) in different quadrants of the mouth and separated by
at least two teeth (or equivalent edentulous space), that meet all of the following
criteria: Tooth with signs of sensitivity, measured by qualifying tactile stimulus
(Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2) on the
facial/ cervical (i.e. labial/ buccal) tooth surface.

Exclusion Criteria:

- A woman who is known to be pregnant or who are intending to become pregnant over the
duration of the study.

- A women who is breast-feeding.

- Known or suspected intolerance or hypersensitivity to the study materials (or closely
related compounds) or any of their stated ingredients.

- Participation in another clinical study (including cosmetic studies) or receipt of an
investigational drug within 30 days of the screening visit and previous participation
in this study.

- Recent history (within the last year) of alcohol or other substance abuse.

- An employee of the sponsor or the study site or members of their immediate family.

- Presence of chronic debilitating disease which, in the opinion of the investigator,
could affect study outcomes and any condition which, in the opinion of the
investigator, causes xerostomia (dry mouth).

- Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing, desensitizing
treatment within 8 weeks of Screening (professional sensitivity treatments and
non-dentifrice sensitivity treatments), gross periodontal disease, treatment of
periodontal disease (including surgery) within 12 months of screening, scaling or root
planning within 3 months of screening and teeth bleaching within 8 weeks of screening.

- Tooth with evidence of current or recent caries, or reported treatment of decay within
12 months of screening and tooth with exposed dentine but with deep, defective or
facial restorations, teeth used as abutments for fixed or removable partial dentures,
dental implants, teeth with full crowns or veneers, orthodontic bands or cracked
enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or
recession of exposed dentine. Sensitive tooth not expected to respond to treatment
with an over-the-counter dentifrice in the opinion of the investigator.

- Use of an oral care product indicated for the relief of dentine hypersensitivity
within 8 weeks of screening (Participants will be required to bring their current oral
care products to the site in order to verify the absence of known anti-sensitivity
ingredients).

- Daily doses of medication/treatments which, in the opinion of the investigator, could
interfere with the perception of pain. Examples of such medications include
analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation,
sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs,
currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline and
daily dose of a medication which, in the opinion of the investigator, is causing
xerostomia.

- Any participant who, in the judgment of the investigator, should not participate in
the study.