Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5% calcium phosphosilicate/ monofluorophosphate dentifrice · 2 trials · 2 indications
Response to a constant jet of air applied to hypersensitive teeth was 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Response to a constant jet of air applied to hypersensitive teeth was 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
Response to a constant jet of air applied to hypersensitive teeth was 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.
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Response to a constant jet of air applied to hypersensitive teeth was 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.
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).
Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).
| Arm | Type | Description |
|---|---|---|
| 5% calcium sodium phosphosilicate/ sodium monofluorophosphate | EXPERIMENTAL | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
| 0% calcium sodium phosphosilicate/sodium monofluorophosphate | ACTIVE_COMPARATOR | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
| Sodium monofluorophosphate | ACTIVE_COMPARATOR | Dentifrice containing 1000 ppmF as sodium monofluorophosphate |
| Sodium fluoride | ACTIVE_COMPARATOR | Dentifrice containing 1100 ppmF as sodium fluoride |
| 5% calcium sodium phosphosilicate/sodium monofluorophosphate | EXPERIMENTAL | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF). |
| Name | Type | Description |
|---|---|---|
| 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice | DRUG | Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate |
| 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice | DRUG | No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate |
| Sodium monofluorophosphate dentifrice | DRUG | Sodium monofluorophospate dentifrice (1000 ppm F) |
| Sodium Fluoride dentifrice | DRUG | Dentifrice containing 1100ppm F as sodium fluoride |
| 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice | DRUG | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
Inclusion Criteria: * Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study. * Participants will be required to have at least four teeth with facial/cervical erosion, abra...