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

NCT ID: NCT02753075

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-08
• Study Completion Date: 2015-12-18

Brief Summary

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.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Oral Rinse 1

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.

Group Type: EXPERIMENTAL

Experimental Oral Rinse 1

Intervention Type: DEVICE

Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5

Fluoride toothpaste

Intervention Type: DRUG

Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate

Experimental Oral Rinse 2

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.

Group Type: EXPERIMENTAL

Experimental Oral Rinse 2

Intervention Type: DEVICE

Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5

Fluoride toothpaste

Intervention Type: DRUG

Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate

Placebo Oral Rinse

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.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Rinse

Intervention Type: OTHER

Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5

Fluoride toothpaste

Intervention Type: DRUG

Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate

Interventions

Experimental Oral Rinse 1

Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5

Intervention Type: DEVICE

Experimental Oral Rinse 2

Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5

Intervention Type: DEVICE

Placebo Oral Rinse

Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5

Intervention Type: OTHER

Fluoride toothpaste

Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

204773

Identifier Type: -

Identifier Source: org_study_id