A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability
A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability
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DOI：
10.1016/j.ajodo.2011.07.024
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发表时间：
2012-02-01
影响因子：
3
通讯作者：
Wheeler, Timothy T.
中科院分区：
文献类型：
--
作者：
McGorray, Susan P.;Dolce, Calogero;Wheeler, Timothy T.
前言：快速移动牙齿和避免治疗后复发是正畸治疗的基本目标。体外和动物研究表明，人类激素松弛素可能通过其对牙周膜的作用来增加移动速度和稳定性。本研究的目的是比较松弛素和安慰剂对人类受试者牙齿移动和稳定性的影响。研究方法：一项单中心、盲法、安慰剂对照、随机临床试验被用来检查松弛素对牙齿移动和稳定性的影响。40名受试者按1：1随机分组，每周注射50 μ g松弛素或安慰剂，持续8周。在第0、2、4和6周分配在治疗过程中被编程为移动目标牙齿2 mm的校准器。每周在扫描和数字化的聚乙烯基硅氧烷印模上测量运动。受试者随访至第12周以评估复发。结果：在8周的治疗期间，治疗组之间的牙齿移动没有差异（P - 0.995）。通过使用意向治疗分析，我们发现两组的平均牙齿移动为0.83 mm（SE，松弛素为0.08，安慰剂为0.09）。两组从第8周到第12周的复发率相同（P = 0.986），平均值为-0.75（标准误，松弛素组为0.07，安慰剂组为0.08）。结论：当比较接受每周注射松弛素的受试者与接受安慰剂的受试者时，在治疗8周或治疗后4周复发的牙齿移动方面没有差异。在两组中，治疗8周后，平均不到一半的程序牙齿移动。松弛素的局部剂量可能太低，不足以影响牙齿移动或短期复发。(Am J Orthod Dentofacial Orthop 2012;141：196-203）
Introduction: Moving teeth rapidly and avoiding posttreatment relapse are fundamental goals of orthodontic treatment. In-vitro and animal studies suggest that the human hormone relaxin might increase the rate of movement and the stability through its effect on the periodontal ligament. The purpose of this study was to compare relaxin and a placebo with regard to tooth movement and stability in human subjects. Methods: A single-center, blinded, placebo-controlled, randomized clinical trial was used to examine the effect of relaxin on tooth movement and stability. Forty subjects were randomized 1: 1 and received weekly injections of 50 mu g of relaxin or a placebo for 8 weeks. Aligners programmed to move a target tooth 2 mm during treatment were dispensed at weeks 0, 2, 4, and 6. Movement was measured weekly on polyvinyl siloxane impressions that were scanned and digitized. The subjects were followed through week 12 to assess relapse. Results: Tooth movement over the 8-week treatment period did not differ by treatment group (P - 0.995). By using an intent-to-treat analysis, we found that the mean tooth movement for both groups was 0.83 mm (SE, 0.08 for relaxin and 0.09 for the placebo). Relapse from weeks 8 to 12 was the same in both groups (P = 0.986), and the mean was -0.75 (SE, 0.07 for relaxin and 0.08 for theplacebo). Conclusions: No differences in tooth movement over 8 weeks of treatment or relapse at 4 weeks posttreatment were detected when comparing subjects who received weekly injections of relaxin with those who received a placebo. In both groups, an average of less than half of the programmed tooth movement was obtained after 8 weeks of treatment. The local doses of relaxin might have been too low to affect tooth movement or short-term relapse. (Am J Orthod Dentofacial Orthop 2012;141:196-203)