Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Dentine Hypersensitivity

Treatments: Drug: Stannous fluoride; Drug: Sodium monofluorophosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01827670

RH01685

Details and patient eligibility

About

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

Enrollment: 119 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.

• Participants with minimum of 20 natural teeth.

• At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.

  1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
  2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
  3. Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

Exclusion criteria

• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
• Any condition which, in the opinion of the investigator, causes dry mouth.
• Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
• Participant using of a desensitising dentifrice within 6 weeks of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 2 patient groups

0.454% stannous fluoride dentifrice

Experimental group

Description:

Participants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water.

Treatment:

Drug: Stannous fluoride

0.76% sodium monofluorophosphate dentifrice

Active Comparator group

Description:

Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.

Treatment:

Drug: Sodium monofluorophosphate