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首页> 外文期刊>American journal of dentistry >A randomized clinical study investigating the staining profile of an experimental stannous fluoride dentifrice
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A randomized clinical study investigating the staining profile of an experimental stannous fluoride dentifrice

机译：一项随机的临床研究，研究了实验性氟化亚锡洁牙剂的染色情况

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Purpose: The primary objective of this study was to investigate the staining profile of an experimental test dentifrice containing 0.454% w/w stannous fluoride compared to that of a marketed control dentifrice containing 0.76% w/w sodium monofluorophosphate (Colgate Cavity Protection) following regular and repeat use, with twice daily brushing over 8 weeks. As an exploratory objective, the staining profile of the test dentifrice was compared to that of a marketed comparator dentifrice containing 0.454% w/w stannous fluoride (Crest Pro-Health - Clean Mint). Methods: This was a single-center, examiner-blind, randomized, three arm, parallel group study, stratified by pre-baseline stain score [total Lobene Stain Index (LSI) (area x intensity) score < 31, > 31] and smoking status. Following initial screening, 137 healthy subjects, aged 18 years and above, with 12 gradable anterior teeth returned for baseline assessments. At the baseline visit, subjects received an oral soft tissue (OST) examination and an assessment of extrinsic dental stain using the LSI on the facial and lingual surfaces of the 12 anterior teeth, LSI area, LSI intensity and LSI area x intensity (the LSI area x intensity score was termed the pre-baseline LSI score). Subjects who met study requirements received a dental prophylaxis of the anterior teeth to remove all visible stain from their tooth surfaces such that an LSI (area x intensity) score of 0 was achieved. Randomized subjects brushed with their assigned dentifrice at home twice daily for 1 timed minute and returned after 4 and 8 weeks for an OST examination and dental stain assessment of the anterior teeth using LSI. Results: There were no statistically significant differences in dental stain build-up between the test dentifrice containing 0.454% w/w stannous fluoride and a marketed control dentifrice (Colgate Cavity Protection), after 4 and 8 weeks of twice daily brushing, in terms of LSI area x intensity, LSI area or LSI intensity scores. Exploratory analysis indicated that the marketed stannous fluoride dentifrice (Crest Pro-Health) exhibited more dental stain build-up at 4 and/or 8 weeks compared to the other two study dentifrices. However, post-hoc analysis revealed an imbalance in LSI baseline stain levels between the treatment groups, with higher stain levels in the marketed comparator group, which made it difficult to draw robust conclusions from the exploratory data. This imbalance was not considered to impact the other study analyses. Study treatments were well tolerated.
机译：目的：本研究的主要目的是研究常规测试后含有0.454％w / w氟化亚锡的实验测试洁牙剂与市售的含有0.76％w / w一氟磷酸钠的对照洁牙剂相比的染色曲线（Colgate腔保护）并重复使用，在8周内每天两次刷牙。作为探索性目的，将测试牙粉的染色曲线与市售的含0.454％w / w氟化亚锡的比较牙粉的染色曲线进行比较（Crest Pro-Health-Clean Mint）。方法：这是一项单中心，盲人，随机，三臂，平行小组研究，按基线前染色评分[总洛宾染色指数（LSI）（面积x强度）评分<31，> 31]进行分层，吸烟状况。初步筛查后，将137名年龄在18岁及以上的健康受试者和12颗可分级前牙送回进行基线评估。在基线访视时，受试者接受口腔软组织（OST）检查，并使用LSI对12颗前牙的面部和舌侧表面进行LSI评估，评估LSI面积，LSI强度和LSI面积x强度（LSI）面积x强度分数称为基线前LSI分数）。达到研究要求的受试者接受了前牙的牙科预防，以去除其牙齿表面的所有可见污渍，从而使LSI（面积x强度）得分达到0。随机分组的受试者每天在家中两次刷牙指定的洁牙剂，每次1分钟，然后在4周和8周后返回以进行OST检查和使用LSI评估前牙的牙齿着色。结果：在每天两次刷牙4周和8周后，含0.454％w / w氟化亚锡的测试洁牙剂与市售的对照洁牙剂（Colgate腔保护）之间，在牙垢堆积方面没有统计学上的显着差异。 LSI面积x强度，LSI面积或LSI强度得分。探索性分析表明，与其他两种研究洁牙剂相比，市售的氟化亚锡洁齿剂（Crest Pro-Health）在4周和/或8周时表现出更多的牙渍堆积。但是，事后分析显示，治疗组之间的LSI基线染色水平不平衡，而上市的比较组中染色水平更高，这使得很难从探索性数据中得出可靠的结论。认为这种失衡不会影响其他研究分析。研究治疗耐受性良好。

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