Leeds Dental Institute, Leeds Belfast Children's Hospital, Belfast Eastman Dental Institute, London, UK.
Dent Traumatol. 2012 Feb;28(1):55-64. doi: 10.1111/j.1600-9657.2011.01053.x. Epub 2011 Oct 11.
Non-setting calcium hydroxide (Ultracal XS(®) ) is recommended by the International Association of Dental Traumatology as the initial medicament following avulsion and replantation for mature teeth. There is experimental evidence to suggest Ledermix(®) , placed as an alternative inter-visit dressing may improve periodontal healing.
This study investigated, using a multi-centre randomized controlled trial, the effect of two root canal medicaments, Ledermix(®) and Ultracal XS(®) , on periodontal healing of avulsed and replanted teeth.
Children were recruited if they fulfilled all inclusion criteria. Treatment followed a standardized protocol. Assessment of periodontal healing or ankylosis was made clinically and radiographically by an experienced, 'blinded', clinician at 12months.
Over 200 patients were assessed for eligibility at five centres. Twenty-nine patients were eligible for inclusion. Final analysis involved 22 patients with 27 teeth. Ankylosis was detected in four of the 12 teeth in the Ledermix(®) group and nine of 15 in the Ultracal XS(®) group. No significant difference between medicaments was found in the proportion of teeth or patients showing periodontal healing.
There was no significant difference in periodontal healing between the two medicaments at either a tooth or patient level. The numbers recruited fell short of an estimated power calculation. For patients meeting the inclusion criteria and completing the trial, periodontal healing was seen in 52% of teeth at the 12-month assessment between both groups. The only factor found to significantly influence the periodontal outcome was dry time.
国际牙外伤学会推荐非凝固型氢氧化钙(Ultracal XS(®))作为成熟恒牙牙脱位再植后的初始药物。有实验证据表明,Ledermix(®)作为一种替代间访敷料,可能会改善牙周愈合。
本研究通过多中心随机对照试验,调查了两种根管内药物(Ledermix(®)和 Ultracal XS(®))对牙脱位再植后牙周愈合的影响。
如果患儿符合所有纳入标准,则将其招募。治疗遵循标准化方案。在 12 个月时,由一名经验丰富的、“盲法”的临床医生进行临床和影像学牙周愈合或骨粘连评估。
在五个中心对 200 多名患者进行了评估,以确定其是否符合入选标准。29 名患者符合纳入标准。最终分析包括 22 名患者的 27 颗牙。在 Ledermix(®)组的 12 颗牙中有 4 颗发生骨粘连,Ultracal XS(®)组的 15 颗牙中有 9 颗发生骨粘连。两种药物在显示牙周愈合的牙齿或患者比例上无显著差异。
在牙齿或患者水平上,两种药物在牙周愈合方面无显著差异。招募的人数低于预计的效力计算。对于符合纳入标准并完成试验的患者,两组在 12 个月评估时,52%的牙齿出现牙周愈合。唯一显著影响牙周结果的因素是干燥时间。