Randomized clinical trial evaluating kinetic benefits of desensitizing agents: Magnitude, onset, and stability of relief

Abstract

BackgroundDentin hypersensitivity (DH) is common, particularly among periodontal patients. This trial evaluated magnitude of desensitizing benefit, onset of action, and complete relief of three dentifrices with distinct desensitizing technologies.MethodsHealthy adults with DH were enrolled and randomized to one of four dentifrices in this randomized, controlled, double‐blind trial: marketed potassium nitrate (KNO3), marketed stannous fluoride (SnF2), experimental 1.5% oxalate, or negative control (NC) monofluorophosphate. Participants brushed with their assigned dentifrice twice daily for 8 weeks, followed by 3 weeks during which all participants used the NC. DH was measured by thermal challenge (Schiff Index) and tactile challenge (Yeaple Probe) at baseline, Day 3, and Weeks 2, 4, 8, and 11.ResultsA total of 120 participants were randomized to treatment, and 118 completed the study. Thermal challenge (Schiff): All treatments provided greater relief than NC at all timepoints (p ≤ 0.004). The SnF2 dentifrice had greater thermal improvements than KNO3 dentifrice at Week 2 (p = 0.021) and in a random coefficients model across all timepoints (p = 0.015). The percentage of participants showing complete relief in at least one test tooth was greater for SnF2 versus KNO3 through Week 8 (all p ≤ 0.044). Tactile challenge (Yeaple Probe): All treatments provided greater tactile sensitivity relief than NC at all timepoints (p ≤ 0.019), except KNO3 at Day 3 (p = 0.197). The SnF2 dentifrice had greater improvements in tactile scores versus the KNO3 dentifrice at Day 3 (p = 0.020).ConclusionSnF2, KNO3, and oxalate dentifrices significantly reduced DH over 8 weeks. SnF2 dentifrice showed the greatest benefits for onset of relief, magnitude of benefit, and complete relief.Trial RegistrationNCT03965039Plain Language SummaryThis study tested four toothpastes for sensitivity relief, including speed and completeness of relief, among approximately 120 adults with sensitive teeth. They were randomly assigned to use one of four toothpastes: commercial toothpaste with potassium nitrate, commercial toothpaste with stannous fluoride, experimental toothpaste with oxalate, or standard fluoride toothpaste (control) with no antisensitivity ingredient. Participants used their toothpaste twice daily for 8 weeks, and then everyone used the control toothpaste for 3 weeks. Sensitivity was measured at the beginning of the study, after 3 days, and after 2, 4, 8, and 11 weeks by blowing cold air on sensitive teeth and moving a probe across the sensitive area (tactile assessment). The potassium nitrate, stannous fluoride, and oxalate toothpastes reduced sensitivity better than the control toothpaste at all times, except potassium nitrate toothpaste at Day 3 for tactile sensitivity. Stannous fluoride toothpaste reduced cold air sensitivity better than potassium nitrate toothpaste at Week 2 and across all times combined. More participants showed complete relief from cold air sensitivity for stannous fluoride toothpaste than potassium nitrate toothpaste through Week 8. Stannous fluoride toothpaste had greater improvements in tactile sensitivity versus potassium nitrate toothpaste at Day 3. Overall, stannous fluoride toothpaste was superior at relieving sensitivity.