Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate.

Randomized Clinical Trial on Sodium Fluoride with Tricalcium Phosphate.
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DOI:
10.1177/0022034520952031
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发表时间:
2021-01
影响因子:
7.6
通讯作者:
Chu CH
Chu CH
中科院分区:
医学1区
文献类型:
--
作者:
Chen KJ;Gao SS;Duangthip D;Lo ECM;Chu CH

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这项为期24个月的随机对照试验是基于双盲平行设计,比较了2种氟化物应用方案在阻止乳牙牙本质龋方面的有效性。招募患有活动性牙本质龋的3岁儿童,并随机分配到2个治疗组。A组的儿童每半年接受一次25%硝酸银(AgNO 3)溶液的应用,然后在龋面上使用含有5%氟化钠(NaF)的市售保护漆。B组的儿童每半年使用一次25%AgNO3溶液,然后使用另一种含有5%NaF的市售清漆,其中含有功能化磷酸三钙(fTCP)。在探查时坚硬的龋齿表面被归类为被阻止。进行意向治疗分析和分层广义线性模型。基线时共招募了408名儿童,1,831个牙齿表面患有活动性牙本质龋,24个月后对356名儿童(87%),1,607个牙齿表面(88%)进行了评估。在24个月评价时,A组(无fTCP)和B组(有fTCP)每名儿童的平均(SD)阻龋牙面数量分别为1.8(2.2)和2.6(3.3)(P = 0.003)。牙面阻滞率A组为42%,B组为57%(P < 0.001)。分层广义线性模型的结果表明,方案B(与fTCP)有较高的预测概率(PP = 0.656),在阻止牙本质龋比方案A(无fTCP; PP = 0.500)时,龋损是在颊/舌面,是在前牙,有牙菌斑覆盖,并从低收入家庭的儿童(P = 0.046)。总之,与方案A相比,方案B(每半年施用25% AgNO 3溶液,然后每半年施用一次市售的5% NaF清漆(不含fTCP))在阻止乳牙牙的牙本质龋方面更有效(ClinicalTrials.gov NCT 03423797)。
This 24-mo randomized controlled trial was based on a double-blind parallel design, and it compared the effectiveness of 2 fluoride application protocols in arresting dentine caries in primary teeth. Three-year-old children with active dentine caries were recruited and randomly allocated to 2 treatment groups. Children in group A received a semiannual application of a 25% silver nitrate (AgNO3) solution followed by a commercially available varnish with 5% sodium fluoride (NaF) on the carious tooth surfaces. Children in group B received a semiannual application of a 25% AgNO3 solution followed by another commercially available varnish with 5% NaF containing functionalized tricalcium phosphate (fTCP). Carious tooth surfaces that were hard when probing were classified as arrested. Intention-to-treat analysis and a hierarchical generalized linear model were undertaken. A total of 408 children with 1,831 tooth surfaces with active dentine caries were recruited at baseline, and 356 children (87%) with 1,607 tooth surfaces (88%) were assessed after 24 mo. At the 24-mo evaluation, the mean (SD) number of arrested carious tooth surfaces per child were 1.8 (2.2) and 2.6 (3.3) for group A (without fTCP) and group B (with fTCP), respectively (P = 0.003). The arrest rates at the tooth surface level were 42% for group A and 57% for group B (P < 0.001). Results of the hierarchical generalized linear model indicated that protocol B (with fTCP) had a higher predicted probability (PP = 0.656) in arresting dentine caries than protocol A (without fTCP; PP = 0.500) when the carious lesions were on buccal/lingual surfaces, were on anterior teeth, had dental plaque coverage, and were in children from low-income families (P = 0.046). In conclusion, protocol B, which applied a 25% AgNO3 solution followed by a commercially available 5% NaF varnish with fTCP semiannually, is more effective in arresting dentine caries in primary teeth as compared with protocol A, which applied a 25% AgNO3 solution followed by another commercially available 5% NaF varnish without fTCP semiannually (ClinicalTrials.gov NCT03423797).
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DOI: 10.1177/2380084416649150
发表时间: 2016-07-01
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