Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Dentine Sensitivity

Treatments: Other: Sodium monofluorophosphate; Device: Calcium sodium phosphosilicate; Other: Sodium fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02371616

202199

Details and patient eligibility

About

An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.

Full description

A single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (DH). This study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from DH after 4 and 8 weeks twice daily treatment.

Enrollment: 304 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subjects in good general health with no clinically significant/ relevant abnormalities of 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) with signs of erosion or abrasion and/or facial/cervical gingival recession (EAR), with a Gingival Index ≤1 and clinical mobility ≤1, and with signs of DH as measured by qualifying evaporative (air) assessment
• 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

• subjects 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+C60
• scaling or root planing 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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304 participants in 2 patient groups

Test dentifrice

Experimental group

Description:

Test dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium flouride

Treatment:

Device: Calcium sodium phosphosilicate

Other: Sodium fluoride

Comparator dentifrice

Active Comparator group

Description:

Comparator dentifrice containing 5% w/w calcium sodium phosphosilicate and 1426 ppm fluoride as sodium monofluorophosphate

Treatment:

Other: Sodium monofluorophosphate

Device: Calcium sodium phosphosilicate