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

一项评估脱敏剂动力学益处的随机临床试验:缓解的程度、起效时间和稳定性

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Abstract

BACKGROUND: Dentin 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. METHODS: Healthy adults with DH were enrolled and randomized to one of four dentifrices in this randomized, controlled, double-blind trial: marketed potassium nitrate (KNO(3)), marketed stannous fluoride (SnF(2)), 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. RESULTS: A 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 SnF(2) dentifrice had greater thermal improvements than KNO(3) 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 SnF(2) versus KNO(3) 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 KNO(3) at Day 3 (p = 0.197). The SnF(2) dentifrice had greater improvements in tactile scores versus the KNO(3) dentifrice at Day 3 (p = 0.020). CONCLUSION: SnF(2), KNO(3), and oxalate dentifrices significantly reduced DH over 8 weeks. SnF(2) dentifrice showed the greatest benefits for onset of relief, magnitude of benefit, and complete relief. TRIAL REGISTRATION: NCT03965039 PLAIN LANGUAGE SUMMARY: This 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.

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