A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

GlaxoSmithKline1 site in 1 country263 target enrollmentFebruary 1, 2016

ConditionsDentin Sensitivity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dentin Sensitivity
Sponsor: GlaxoSmithKline
Enrollment: 263
Locations: 1
Primary Endpoint: Change From Baseline in Schiff Sensitivity Score on Day 3
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This single centre, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.

Registry

clinicaltrials.gov

Start Date

February 1, 2016

End Date

June 17, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
•Good general and mental health with, in the opinion of the investigator or medically qualified designee:
•A. No clinically significant and relevant abnormalities in medical history or upon oral examination.
•B. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
•Dental health
•At Screening:
•A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
•B. Good general oral health, with a minimum of 20 natural teeth.
•C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
•Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).

Exclusion Criteria

•Pregnant or breast feeding women
•Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
•Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
•Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. - 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 xerostomia.
•Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
•Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
•Recent history (within the last year) of alcohol or other substance abuse
•Dental prophylaxis within four weeks of Screening.
•Tongue or lip piercing or presence of dental implants.

Outcomes

Primary Outcomes

Change From Baseline in Schiff Sensitivity Score on Day 3

Time Frame: Baseline to Day 3

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.

Secondary Outcomes

Change From Baseline in Tactile Threshold on Day 3(Baseline to Day 3)
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application(Baseline to 60 seconds post first treatment)
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application(Baseline to 60 seconds post first treatment)