Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity

• Stannous Fluoride (Drug): dentifrice containing stannous fluoride
• Sodium Monofluorophosphate (Drug): dentifrice containing Sodium Monofluorophosphate

Primary outcomes

• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 [Baseline to Day 14]: Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.

Secondary outcomes

• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment [Baseline to immediately post treatment administration]: Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.
• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 [Baseline to Day 3]: Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.
• Change From Baseline in Tactile Pain Threshold Score at Day 14 [Baseline to Day 14]: The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity
• Change From Baseline in Tactile Pain Threshold Score at Day 3 [Baseline to Day 3]: The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.
• Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment [Baseline to immediately post treatment administration]: The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

\- Subjects who suffer from tooth sensitivity.

Participant flow

Outcome results

• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 (Primary), Mean, Score on a scale: SnF Dentifrice -1.20 +/- 0.70; NaMFP Dentifrice -0.37 +/- 0.43 (p <0.0001)
• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment (Secondary), Mean, Score on a scale: SnF Dentifrice -0.40 +/- 0.46; NaMFP Dentifrice -0.14 +/- 0.35 (p 0.0006)
• Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 (Secondary), Mean, Score on a scale: SnF Dentifrice -0.70 +/- 0.60; NaMFP Dentifrice -0.25 +/- 0.39 (p <0.0001)
• Change From Baseline in Tactile Pain Threshold Score at Day 14 (Secondary), Mean, Force (grams): SnF Dentifrice 22.9 +/- 21.14; NaMFP Dentifrice 3.5 +/- 5.67 (p <0.0001)
• Change From Baseline in Tactile Pain Threshold Score at Day 3 (Secondary), Mean, Force (grams): SnF Dentifrice 9.8 +/- 15.52; NaMFP Dentifrice 3.0 +/- 4.90 (p 0.0021)
• Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment (Secondary), Mean, Force (grams): SnF Dentifrice 5.8 +/- 10.17; NaMFP Dentifrice 1.9 +/- 3.24 (p 0.0070)

Adverse events

Time frame: All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.

• Results publication: Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32. PMID 27093773

• GSK Clinical Trials, Study director, GlaxoSmithKline