Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

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Detailed Description

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This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.

Conditions

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Dentinal Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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5% calcium sodium phosphosilicate/ sodium monofluorophosphate

Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

Group Type EXPERIMENTAL

5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

Intervention Type DRUG

Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate

0% calcium sodium phosphosilicate/sodium monofluorophosphate

Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

Group Type ACTIVE_COMPARATOR

0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

Intervention Type DRUG

No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate

Sodium monofluorophosphate

Dentifrice containing 1000 ppmF as sodium monofluorophosphate

Group Type ACTIVE_COMPARATOR

Sodium monofluorophosphate dentifrice

Intervention Type DRUG

Sodium monofluorophospate dentifrice (1000 ppm F)

Sodium fluoride

Dentifrice containing 1100 ppmF as sodium fluoride

Group Type ACTIVE_COMPARATOR

Sodium Fluoride dentifrice

Intervention Type DRUG

Dentifrice containing 1100ppm F as sodium fluoride

Interventions

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5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate

Intervention Type DRUG

0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate

Intervention Type DRUG

Sodium monofluorophosphate dentifrice

Sodium monofluorophospate dentifrice (1000 ppm F)

Intervention Type DRUG

Sodium Fluoride dentifrice

Dentifrice containing 1100ppm F as sodium fluoride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
* Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.

Exclusion Criteria

* Specific Dentition Exclusions for Test teeth

1. Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
2. Tooth with exposed dentin 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 etiologies other than erosion, abrasion or recession of exposed dentin.
3. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
* Use of a sensitivity dentifrice within 8 weeks of screening
* Individuals who require antibiotic prophylaxis for dental procedures

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes