Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02832375 | Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity | PHASE3 | COMPLETED | 242 | — | — | Mar 1, 2016 | May 12, 2016 | May 25, 2017 | 1 | United States |
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.
| 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. |
| 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...