A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Dentin Sensitivity

Treatments: Device: Experimental Oral Rinse 2; Other: Placebo Oral Rinse; Drug: Fluoride toothpaste; Device: Experimental Oral Rinse 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02753075

204773

Details and patient eligibility

About

This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Enrollment: 240 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in good general health with no clinically significant/ relevant abnormalities in medical history or upon oral examination
• Pre-existing self reported and clinically diagnosed tooth sensitivity
• At screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) preferably in different quadrants with a signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR),tooth with modified gingival index (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).
• At baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with DH (qualifying tactile threshold Yeaple ≤ 20g, Schiff Sensitivity Score ≥ 2)

Exclusion criteria

• Participants with a known or suspected intolerance or hypersensitivity to study products
• Presence of chronic debilitating disease which could affect study outcomes
• Any condition which is causing dry mouth
• Use of an oral care product indicated for the relief of dentine hypersensitivity
• Participation in a DH treatment study in the 8 weeks prior to screening
• Taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth
• Require antibiotic prophylaxis for dental procedures
• Dental prophylaxis within 4 weeks of screening
• Treatment of periodontal disease within 12 months of screening
• Scaling or root planning within 3 months of screening
• Tooth bleaching within 8 weeks of screening
• Active caries or periodontitis
• Partial dentures, orthodontic appliances or dental implants which could affect study outcomes
• Pregnant and breast-feeding females
• Main Exclusions for Test Teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; 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 or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups, including a placebo group

Experimental Oral Rinse 1

Experimental group

Description:

Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks.

Treatment:

Drug: Fluoride toothpaste

Device: Experimental Oral Rinse 1

Experimental Oral Rinse 2

Experimental group

Description:

Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.

Treatment:

Drug: Fluoride toothpaste

Device: Experimental Oral Rinse 2

Placebo Oral Rinse

Placebo Comparator group

Description:

Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.

Treatment:

Other: Placebo Oral Rinse

Drug: Fluoride toothpaste