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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-29

Study Completion Date

2014-12-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dentine Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Test dentifrice

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

Group Type EXPERIMENTAL

Calcium sodium phosphosilicate

Intervention Type DEVICE

5% w/w calcium sodium phosphosilicate

Sodium fluoride

Intervention Type OTHER

1426 ppm fluoride as sodium fluoride

Comparator dentifrice

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

Group Type ACTIVE_COMPARATOR

Calcium sodium phosphosilicate

Intervention Type DEVICE

5% w/w calcium sodium phosphosilicate

Sodium monofluorophosphate

Intervention Type OTHER

1426 ppm fluoride as sodium monofluorophosphate

Interventions

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Calcium sodium phosphosilicate

5% w/w calcium sodium phosphosilicate

Intervention Type DEVICE

Sodium fluoride

1426 ppm fluoride as sodium fluoride

Intervention Type OTHER

Sodium monofluorophosphate

1426 ppm fluoride as sodium monofluorophosphate

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes