A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

GlaxoSmithKline1 site in 1 country221 target enrollmentJanuary 4, 2016

ConditionsDentin Sensitivity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dentin Sensitivity
Sponsor: GlaxoSmithKline
Enrollment: 221
Locations: 1
Primary Endpoint: Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.

Registry

clinicaltrials.gov

Start Date

January 4, 2016

End Date

April 22, 2016

Last Updated

7 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.
•Participants will be male or female aged between 18 and 65 years inclusive.
•Good general and mental health with, in the opinion of the investigator or medically qualified designee.
•No clinically significant and relevant abnormalities in medical history or upon oral examination.
•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.
•Self-reported history of dentinal hypersensitivity (DH) lasting more than(\>) six months but not \> 10 years.
•Good general oral health, with a minimum of 20 natural teeth.
•Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.

Exclusion Criteria

•Women who are pregnant or breast-feeding .
•Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
•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 kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
•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.
•Previous participation in this study.

Outcomes

Primary Outcomes

Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)

Time Frame: Baseline and Week 8

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

Secondary Outcomes

Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8(Baseline, Week 4 and 8)
Change From Baseline in Tactile Threshold at Week 4 and 8(Baseline, Week 4 and 8)
Change From Baseline in Schiff Sensitivity Score at Week 4(Baseline and Week 4)
Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)(Baseline and Week 8)