A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Potassium oxalate; Sodium fluoride; Placebo
Intervention description: Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride; Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF); Oral rinse containing 0% KOX and 0 ppm fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate
      (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after
      8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Demonstrates understanding of the study procedures, restrictions and willingness to
             participate as evidenced by voluntary written informed consent and has received a
             signed and dated copy of the informed consent form.

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee: a) No clinically significant and relevant abnormalities in medical
             history or oral Examination and b) Absence of any condition that would impact on the
             participant's safety or wellbeing or affect the individual's ability to understand and
             follow study procedures and requirements.

          -  Dental Health at Screening: a) Self-reported history of DH lasting more than six
             months but not more than 10 Years, b) Minimum of 20 natural teeth, c) Minimum of 4
             accessible non-adjacent teeth (incisors, canines, premolars), preferably in different
             quadrants, that meet all of the following criteria: Signs of facial/cervical 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 (Schiff
             sensitivity score ≥ 2).

          -  Dental Health at Baseline: Minimum of two, non-adjacent accessible teeth (incisors,
             canines, premolars), 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.

          -  Females of childbearing potential who are, in the opinion of the investigator,
             practicing a reliable method of contraception. Adequate contraception is defined as
             abstinence, oral contraceptive, either combined or progestogen alone or injectable
             progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous
             contraceptive patches or intrauterine device or intrauterine system or double barrier
             method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal
             agent [foam, gel, film, cream, suppository]) or male partner sterilization prior to
             the female participant's entry into the study, and this male is the sole partner for
             that participant).

          -  Participant will be current and regular (twice daily), users of an over the counter
             (OTC) Monograph or cosmetic oral rinse.

          -  Participant will be cell phone owners so that they can contactable by SMS.

        Exclusion Criteria:

          -  A woman who is known to be pregnant or who is intending to become pregnant over the
             duration of the study.

          -  A woman 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 or 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.

          -  Any condition which, in the opinion of the investigator, causes xerostomia.

          -  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.

          -  Teeth bleaching and any teeth whitening procedures within 8 weeks of Screening.

          -  Tooth with evidence of current or recent caries, or reported treatment of decay within
             12 months of Screening.

          -  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 two weeks of Baseline.

          -  Daily dose of a medication which, in the opinion of the investigator, is causing
             xerostomia.

          -  Presence of kidney disease, hyperoxaluria, or any other condition that may be
             exacerbated by oxalic acid or oxalate salts.

          -  Presence of chronic debilitating disease which, in the opinion of the investigator,
             could affect study outcomes.

          -  Any participant who, in the judgment of the investigator, should not participate in
             the study.