Dose Response of a Tubule Occlusion Agent
Condition: Dentine Hypersensitivity; Dental Pain
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: 5% calcium sodium phosphosilicate toothpaste; 7.5% calcium sodium phosphosilicate toothpaste; Placebo toothpaste
Intervention description: Low concentration calcium sodium phosphosilicate tubule occlusion agent; High concentration calcium sodium phosphosilicate tubule occlusion agent; Placebo toothpaste
Intervention MeSH terms: Calcium, Dietary; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: sensitivity; occlusion

Summary:

      To evaluate the efficacy of two different concentrations of a tubule occlusion agent -
      calcium sodium phosphosilicate in treatment of dentine hypersensitivity
    

Eligibility criteria:

        Inclusion Criteria:

          1. Consent: Demonstrates understanding of the study and willingness to participate as
             evidenced by voluntary written informed consent and has received a signed and dated
             copy of the informed consent form.

          2. Age: Aged between 20 - 50 years.

          3. General Health: Good general health with (in the opinion of the investigator) no
             clinically significant and relevant abnormalities of medical history.

          4. Contraception: Females of childbearing potential who are, in the opinion of the
             investigator, practising a reliable method of contraception.

          5. Erosion/Abrasion/Recession:Study teeth must show signs of facial/cervical erosion,
             abrasion and/or gingival recession.

          6. Gingival Health / Tooth Mobility Grade:Study teeth must have Löe and Silness Gingival
             Index (GI) score less than or equal to 2 and clinical mobility less than or equal to
             grade I.

          7. Current Product Use: Participants must have been using the same brand of toothpaste
             for at least 2 months and should not have used desensitizing toothpaste during the 4
             weeks preceding screening. Participants will be required to bring in their current
             toothpaste(s) in order to verify the ingredients.

          8. VAS Training: Successfully completes the VAS training exercise at Screening.

          9. Sensitivity: Self-reported history of dentinal hypersensitivity and a primary
             complaint of sensitive teeth lasting a maximum of 10 years. At Screening: A minimum of
             5 evaporative (air) sensitive lateral incisors, canines or pre-molars must display a
             response greater than 25 mm on a 100 mm VAS. At Baseline: A minimum of 3 of the 5
             evaporative (air) sensitive teeth identified at screening must display a response
             greater than 25 mm on a 100 mm VAS. All teeth meeting the sensitivity Inclusion
             Criteria will be followed and assessed using both efficacy parameters.

         10. Compliance: Understands and is willing, able and likely to comply with all study
             procedures and restrictions.

        Exclusion Criteria:

          1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant
             over the duration of the study.

          2. Breast-feeding: Women who are breast-feeding.

          3. Medical History: a) Chronic debilitating disease is present b)Chronic disease or other
             condition is present that is associated with intermittent episodes or constant daily
             pain, such as arthritis, low back pain, dysmenorrhea, etc.

          4. Medications: Daily doses of medication, which in the opinion of the investigator,
             might interfere with the perception of pain, are being taken. Examples of such
             medications include analgesics, anticonvulsants, antihistamines that cause marked or
             moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory
             drugs.

          5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an
             over-the- counter (OTC) dentifrice in the opinion of the investigator. b) Teeth with
             exposed dentine but with deep, defective or facial restorations, teeth used as
             abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic
             bands, extensive caries or cracked enamel. Sensitive teeth with contributing
             aetiologies other than erosion, abrasion or recession of exposed dentine. c) Dental
             professional hygiene (includes dental prophylaxis, irrigation, and intensive
             anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence
             of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within
             the past 6 months or have been scaled /root planed within the past 3 months.

          6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          7. Clinical Study/Experimental Medication: a) Participation in another clinical study or
             receipt of an investigational drug within 30 days of the screening visit.b) Previous
             participation in this study.

          8. Xerostomia: Any condition or medication that causes xerostomia.

          9. Personnel: An employee of the sponsor or the study site or members of their immediate
             family.

         10. Other: Any subject who in the opinion of the investigator, should not participate in
             the study.