Acevedo Ana Maria, Machado Carolina, Rivera Luis E, Wolff Mark, Kleinberg Israel
Institute of Dental Research, Faculty of Dentistry, Central University of Venezuela, Caracas, Venezuela.
J Clin Dent. 2005;16(3):63-70.
This study assessed the effect of an arginine bicarbonate/calcium carbonate (CaviStat)-containing dentifrice on caries development, mainly in 11- to 12-year-old Venezuelan children over a two-year period.
Children (726) with a DMFT between 3 and 6 were examined at baseline, six months, and one and two years using a mirror, probe, and DMFS scoring. Subjects who completed the study consisted of two groups; 304 test and 297 control. The test group received a CaviStat-containing dentifrice, and the controls used a commercially available 1100 ppm fluoride toothpaste. All subjects were instructed to brush three times a day for 1 minute followed by swishing for 30 seconds.
After six months, the mean DMFS scores increased only slightly from baseline in both groups, 6.93 +/- 0.22 in the control and 6.59 +/- 0.22 in the test subjects. After one year, the mean DMFS score in the control group rose to 8.00 +/- 0.24 and leveled off at 7.92 +/- 0.30 at two years. In contrast, the mean DMFS score in the test group decreased to 5.50 +/- 0.24 after one year before rising to 6.99 +/- 0.28 at two years. DMFS difference between the two groups was highly significant (p < 0.001), but mainly due to the large difference seen at one year. Dissection of the data showed that the erupted first molars dominated the overall DMFS changes. At the beginning of this study, first molar scores started at high values and showed a pattern thereafter like that seen for the total data. In contrast, premolars/molars, which erupt 4-6 years later (and at the start of the study had a mean DMFS score slightly above zero), showed a clear rise in the DMFS score in the control group during the first year of the study, which continued to rise until the end of the investigation. In contrast, the CaviStat group showed no change in the premolar/second molar DMFS score from baseline during the first year (giving the impression of 100% inhibition at one year), but showed a delayed rise thereafter that paralleled that seen in the controls between one and two years (58.3% inhibition at two years). Reversal of the development of early dental caries lesions in the CaviStat subjects and limitations of the diagnosis of very early caries lesions with standard dental explorers was suggested for the interesting first molar, first year data. Inhibition of caries initiation and caries progression in the CaviStat group was also observed and easier to see in the premolar/second molar, second year data where the DMFS scores were very low at baseline and reversals are not a significant issue. The results were subjected to statistical analysis including analysis of covariance. Largely because of the first year and first molar data, the difference between control and experimental groups was highly significant (p < 0.001). Similar comparison with the later-erupting premolar/molar teeth showed the CaviStat effect was also significant but at a lower level (p < 0.05). The differences could not be due to examiner error since the Kappa for 10% of the subjects randomly selected and re-examined was 0.898 overall and 0.914 for the first molar data. The data also suggested CaviStat inhibition of caries progression because of a slower rate of rise of missing+filled teeth in the CaviStat vs. the control group (p < 0.05).
A CaviStat-containing toothpaste was more effective both clinically and statistically in inhibiting caries initiation and progression than the fluoride toothpaste control, and manifested its effects differently in the already-erupted first molars than in the later-erupting premolars and second molars.
本研究评估了含精氨酸碳酸氢盐/碳酸钙(CaviStat)的牙膏对龋齿发展的影响,主要针对11至12岁的委内瑞拉儿童,为期两年。
对726名龋失补指数(DMFT)在3至6之间的儿童在基线、6个月、1年和2年时进行检查,使用镜子、探针和DMFS评分。完成研究的受试者分为两组;304名试验组和297名对照组。试验组使用含CaviStat的牙膏,对照组使用市售的1100 ppm氟牙膏。所有受试者均被指示每天刷牙3次,每次1分钟,随后漱口30秒。
6个月后,两组的平均DMFS评分仅比基线略有增加,对照组为6.93±0.22,试验组受试者为6.59±0.22。1年后,对照组的平均DMFS评分升至8.00±0.24,并在2年时稳定在7.92±0.30。相比之下,试验组的平均DMFS评分在1年后降至5.50±0.24,然后在2年时升至6.99±0.28。两组之间的DMFS差异非常显著(p<0.001),但主要是由于1年时出现的巨大差异。对数据的剖析表明,已萌出的第一磨牙主导了总体DMFS变化。在本研究开始时,第一磨牙的评分起始值较高,此后呈现出与总数据相似的模式。相比之下,在4至6年后萌出的前磨牙/磨牙(在研究开始时平均DMFS评分略高于零),在研究的第一年,对照组的DMFS评分明显上升,并持续上升直至研究结束。相比之下,CaviStat组在前磨牙/第二磨牙的DMFS评分在第一年与基线相比没有变化(给人在1年时100%抑制的印象),但此后出现延迟上升,与对照组在1至2年期间的上升情况相似(2年时抑制率为58.3%)。对于有趣的第一磨牙第一年的数据,提示CaviStat组早期龋齿病变发展的逆转以及使用标准牙科探针诊断极早期龋齿病变的局限性。在CaviStat组中也观察到了龋齿起始和进展的抑制,在前磨牙/第二磨牙的第二年数据中更容易看出,其中基线时DMFS评分非常低,逆转不是一个重要问题。对结果进行了包括协方差分析在内的统计分析。很大程度上由于第一年和第一磨牙的数据,对照组和试验组之间的差异非常显著(p<0.001)。与后期萌出的前磨牙/磨牙进行类似比较显示,CaviStat的效果也很显著,但程度较低(p<0.05)。差异不可能是由于检查者误差,因为随机选择并重新检查的10%受试者的卡帕值总体为0.898,第一磨牙数据为0.914。数据还表明,由于CaviStat组中缺失+充填牙的上升速度比对照组慢(p<0.05),CaviStat对龋齿进展有抑制作用。
含CaviStat的牙膏在临床和统计学上比氟牙膏对照组更有效地抑制龋齿的起始和进展,并且在已萌出的第一磨牙中与后期萌出的前磨牙和第二磨牙中表现出不同的效果。