Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Stannous Fluoride · 6 trials · 3 indications
Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60\[degrees(deg)\] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds\[sec\])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results.
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
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.
Schiff sensitivity score was assessed by examiner as 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
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.
| Arm | Type | Description |
|---|---|---|
| Experimental: stannous fluoride | EXPERIMENTAL | Participants will be instructed to dose a dry toothbrush containing 0.454% w/w of stannous fluoride (1000 parts per million \[ppm\] fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. |
| Standard: sodium monofluorophosphate | ACTIVE_COMPARATOR | Participants will be instructed to dose a dry toothbrush containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. |
| Experimental Test Dentifrice | EXPERIMENTAL | In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. |
| Control Dentifrice | PLACEBO_COMPARATOR | In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings. |
| 0.454% stannous fluoride dentifrice | EXPERIMENTAL | Participants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water. |
| 0.76% sodium monofluorophosphate dentifrice | ACTIVE_COMPARATOR | Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water. |
| Arm 1 | EXPERIMENTAL | Dentifrice containing stannous fluoride |
| Arm 2 | ACTIVE_COMPARATOR | Marketed dentifrice containing Sodium Monofluorophosphate |
| Dentifrice containing stannous fluoride | EXPERIMENTAL | Toothpaste |
| Dentifrice containing Sodium Monofluorophosphate | ACTIVE_COMPARATOR | Toothpaste |
| Name | Type | Description |
|---|---|---|
| stannous fluoride | DRUG | 0.454% w/w stannous fluoride containing 1100ppm of fluoride |
| sodium monofluorophosphate | DRUG | 0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride |
Inclusion Criteria: * Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Aged 18-65 years inclusive * Understands and is willing, able and likely to comply...
Stannous fluoride is used in dentifrice formulations for dentin sensitivity, dentine hypersensitivity, and gingivitis. GSK plc has studied it in Phase 3 clinical trials across these oral care indications, with completed studies enrolling adults aged 18 years and older in the United States and Ireland.
GSK plc, which trades under the ticker GSK, is the developer of the stannous fluoride dentifrice studied in these clinical programs. The company sponsored the Phase 3 trials evaluating the ingredient for gingivitis and dentinal hypersensitivity indications.
Stannous fluoride has been evaluated in Phase 3 clinical development. Four Phase 3 trials have been completed, and none are currently active. The studies were randomized, double-blind, and active-controlled, with a combined enrollment of 472 participants.
Completed Phase 3 trials include NCT04123665 in gingivitis, NCT03072719 and NCT01827670 in dentine hypersensitivity, and NCT02832375 in dentin sensitivity. These studies enrolled 98, 120, 119, and 242 participants respectively, and were conducted in the United States and Ireland.
Stannous fluoride has completed Phase 3 clinical development for dentin sensitivity, dentine hypersensitivity, and gingivitis. The trials were randomized, double-blind, and active-controlled, and all four studies have been completed with no active trials ongoing.