BACKGROUND Dentine hypersensitivity can impact functional status and everyday activities such as eating and talking. This study aimed to assess changes in oral health-related quality of life measures in individuals with dentine hypersensitivity following long-term use (24 weeks) of a commercially available toothpaste marketed for dentine hypersensitivity relief. METHODS This study was conducted across two sites and enrolled 75 adults with ≥2 non-adjacent sensitive teeth. Participants were assigned to twice-daily brushing with toothpaste containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Every 4 weeks, participant-reported outcomes were assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ), a condition specific oral health-related quality of life scale that has five domains and includes questions on social and emotional impact, restrictions, adaptations and effect on life overall. Responses to a clinically applied evaporative (air) stimulus were assessed using the examiner-observed Schiff sensitivity scale and Labelled Magnitude Scales (LMS), which included dentine hypersensitivity-specific descriptors of intensity, duration, tolerability and descriptive qualities of the participant's response. RESULTS Participant-reported outcomes demonstrated reduction of the impact of dentine hypersensitivity over time on health-related quality of life, as measured by the DHEQ. This reached statistical significance from Week 8 onwards (p < 0.0001 versus baseline) for the Total DHEQ score, with scores continually decreasing at each timepoint. Most domain scores followed a similar pattern. Statistically significant reductions were also detected for the examiner-observed Schiff Sensitivity Scale scores at all timepoints (including at 4 weeks) (p < 0.05), which were mirrored by LMS responses. The toothpaste was generally well-tolerated. CONCLUSIONS These results show that long-term use of a sensitivity toothpaste containing 0.454% w/w stannous fluoride has a beneficial, ongoing, impact on the oral health-related quality of life of people with dentine hypersensitivity. TRIAL REGISTRATION This study was registered at Clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT02752958 ) on April 27, 2016.

中文翻译：

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牙膏对牙本质过敏症患者口腔健康相关生活质量的影响。

背景技术牙本质过敏症可影响功能状态和日常活动，例如进食和说话。这项研究旨在评估长期使用（24周）市售可缓解牙本质过敏症的市售牙膏后，患有牙本质过敏症的人口腔健康相关的生活质量衡量指标的变化。方法本研究在两个地点进行，招募了75具≥2颗不相邻的敏感牙齿的成年人。参与者被分配每天两次刷牙，牙膏中含有0.454％w / w的氟化亚锡（1100 ppm氟化物）。每隔4周，使用牙本质过敏经验问卷（DHEQ）对参与者报告的结局进行评估，与特定条件有关的口腔健康相关生活质量量表，具有五个领域，包括有关社会和情感影响，限制，适应和对整体生活的影响的问题。使用检查员观察到的席夫（Schiff）敏感性量表和标记幅度量表（LMS）评估对临床应用的蒸发（空气）刺激的反应，其中包括参与者反应强度，持续时间，耐受性和描述性的牙本质超敏性特定描述符。结果参与者报告的结果表明，随着时间的流逝，通过DHEQ评估，牙本质过敏症对健康相关的生活质量的影响减少。从第8周起，对于DHEQ的总得分，这达到了统计学意义（相对于基线，p <0.0001），分数在每个时间点持续下降。大多数领域分数遵循类似的模式。在所有时间点（包括第4周），检查员观察到的Schiff敏感性量表得分也均在统计学上显着降低（p <0.05），这与LMS的反应相吻合。牙膏通常耐受性良好。结论这些结果表明，长期使用含有0.454％w / w氟化亚锡的敏感性牙膏会对牙本质过敏症患者的口腔健康相关生活质量产生有益的，持续的影响。试验注册该研究于2016年4月27日在Clinicaltrials.gov（https://clinicaltrials.gov/ct2/show/NCT02752958）上进行了注册。在所有时间点（包括第4周），检查员观察到的Schiff敏感性量表得分也均在统计学上显着降低（p <0.05），这与LMS的反应相吻合。牙膏通常耐受性良好。结论这些结果表明，长期使用含有0.454％w / w氟化亚锡的敏感性牙膏会对牙本质过敏症患者的口腔健康相关生活质量产生有益的，持续的影响。试验注册该研究于2016年4月27日在Clinicaltrials.gov（https://clinicaltrials.gov/ct2/show/NCT02752958）上进行了注册。在所有时间点（包括第4周），检查员观察到的Schiff敏感性量表得分也均在统计学上显着降低（p <0.05），这与LMS的反应相吻合。牙膏通常耐受性良好。结论这些结果表明，长期使用含有0.454％w / w氟化亚锡的敏感性牙膏会对牙本质过敏症患者的口腔健康相关生活质量产生有益的，持续的影响。试验注册该研究于2016年4月27日在Clinicaltrials.gov（https://clinicaltrials.gov/ct2/show/NCT02752958）上进行了注册。结论这些结果表明，长期使用含有0.454％w / w氟化亚锡的敏感性牙膏会对牙本质过敏症患者的口腔健康相关生活质量产生有益的，持续的影响。试验注册该研究于2016年4月27日在Clinicaltrials.gov（https://clinicaltrials.gov/ct2/show/NCT02752958）上进行了注册。结论这些结果表明，长期使用含有0.454％w / w氟化亚锡的敏感性牙膏会对牙本质过敏症患者的口腔健康相关生活质量产生有益的，持续的影响。试验注册该研究于2016年4月27日在Clinicaltrials.gov（https://clinicaltrials.gov/ct2/show/NCT02752958）上进行了注册。