The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.
This study will be a single centre, randomised, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 8 weeks, to investigate the clinical efficacy of a SnF2 dentifrice in the reduction of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialised negative and positive control dentifrices. Participants will be instructed to brush teeth with their assigned dentifrice according to the product use instructions provided. DH assessments will be conducted at Baseline, 4 and 8 weeks. Participants will also be requested to complete a short-form version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) at the Baseline and Week 8 Visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
271
Sensodyne Sensitivity \& Gum toothpaste containing 0.454% SnF2.
Crest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride.
Sensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate.
GSK Investigational Site
Shanghai, China
Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were 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. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Time frame: Baseline and Week 8
Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control)
Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20 gram (g) and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth were determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses were recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Time frame: Baseline, Week 4 and 8
Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, 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. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and Week 4
Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control)
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, 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. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control)
Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20g and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses would be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.
Time frame: Baseline, Week 4 and Week 8