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

NCT ID: NCT01827670

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-05-31

Brief Summary

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.

Conditions

Dentine Hypersensitivity

Study Design

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

Study Groups

0.454% stannous fluoride dentifrice

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.

Group Type: EXPERIMENTAL

Stannous fluoride

Intervention Type: DRUG

Test dentifrice containing 0.454% SnF

0.76% sodium monofluorophosphate dentifrice

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.

Group Type: ACTIVE_COMPARATOR

Sodium monofluorophosphate

Intervention Type: DRUG

Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate \[1000 parts per million (ppm) fluoride\]

Interventions

Stannous fluoride

Test dentifrice containing 0.454% SnF

Intervention Type: DRUG

Sodium monofluorophosphate

Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate \[1000 parts per million (ppm) fluoride\]

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Salus Research, Inc.

Fort Wayne, Indiana, United States

Countries

United States

References

Parkinson CR, Jeffery P, Milleman JL, Milleman KR, Mason S. Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial. Am J Dent. 2015 Aug;28(4):190-6.

Reference Type: DERIVED

PMID: 26437498 (View on PubMed)

Other Identifiers

RH01685

Identifier Type: -

Identifier Source: org_study_id