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A randomised bite force study assessing two currently marketed denture adhesive products compared with no‐adhesive control

机译:随机咬合力研究评估了目前销售的伪造粘合剂产品与无粘度控制相比

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摘要

Abstract Unlike other oral care products, there are limited technologies in the denture adhesive category with the majority based on polymethyl vinyl ether/maleic anhydride (PVM/MA) polymer. Carbomer‐based denture adhesives are less well studied, and there are few clinical studies directly comparing performance of denture adhesives based on different technologies. This single‐centre, randomised, three‐treatment, three‐period, examiner‐blind, crossover study compared a carbomer‐based denture adhesive (Test adhesive) with a PVM/MA‐based adhesive (Reference adhesive) and no adhesive using incisal bite force measurements (area over baseline over 12 hr; AOB0–12) in participants with a well‐made and at least moderately well‐fitting complete maxillary denture. Eligible participants were randomised to a treatment sequence and bit on a force transducer with increasing force until their maxillary denture dislodged. This procedure was performed prior to treatment application (baseline) and at 0.5, 1, 3, 6, 9, and 12 hr following application. Forty‐four participants were included in the modified intent‐to‐treat population. AOB0–12 favoured both Test adhesive to No adhesive (difference: 2.12 lbs; 95% CI [1.25, 3.00]; p < 0.0001) and Reference adhesive to No adhesive (difference: 2.76 lbs; 95% CI [1.89, 3.63]; p < 0.0001). There was a numerical difference in AOB0–12 for Test versus Reference adhesive (−0.63 lbs; [−1.51, 0.25]); however, this was not statistically significant (p = 0.1555). Treatments were generally well tolerated. Both PVM/MA and carbomer‐based denture adhesives demonstrated statistically significantly superior denture retention compared with no adhesive over 12 hr, with no statistically significant difference between adhesives.
机译:摘要与其他口腔护理产品不同,义齿粘合剂类别有限,基于聚甲基乙烯基醚/马来酸酐(PVM / MA)聚合物的多数。基于Carbomer的义齿粘合剂的研究较少,并且很少有临床研究直接比较义齿粘合剂的性能,基于不同的技术。该单中心,随机,三种治疗,三期,检查盲,交叉研究与PVM / MA基粘合剂(参考粘合剂)的基于Carbomer的义齿粘合剂(试验粘合剂)与使用切口咬合的粘合剂进行比较。在参与者中,在参与者中强制测量(面积超过12小时; AOB0-12),具有良好的,并且至少适中良好地完善的上颌义齿。符合条件的参与者随机被随机化为在力换能器上的处理序列和位,直到其上颌义齿移位。在治疗施用(基线)和0.5,1,3,6,9和12小时之前进行该方法进行。在修改的意图对治疗人口中包含四十四名参与者。 AOB0-12对无粘合剂的测试粘合剂(差异:2.12磅; 95%CI [1.25,3.00]; P <0.0001)和NO粘合剂的参考粘合剂(差异:2.76磅; 95%CI [1.89,3.63]; P <0.0001)。 AOB0-12有一个数值差异,用于测试与参考粘合剂(-0.63磅; [-1.51,0.25]);然而,这在统计学上没有统计学意义(P = 0.1555)。通常耐受性耐受性。 PVM / MA和基于Carbomer的义齿粘合剂均在12小时内没有粘合剂呈现统计学显着优异的义齿潴留,粘合剂之间没有统计学上显着的差异。

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