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恒牙不可逆性牙髓炎活髓治疗的两年结果:一项正在进行的多中心随机临床试验。

Two-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter randomized clinical trial.

作者信息

Asgary Saeed, Eghbal Mohammad Jafar, Ghoddusi Jamileh

机构信息

Iranian Center for Endodontic Research, Research Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences, Evin, 1983963113, Tehran, Iran,

出版信息

Clin Oral Investig. 2014;18(2):635-41. doi: 10.1007/s00784-013-1003-6. Epub 2013 May 28.

DOI:10.1007/s00784-013-1003-6
PMID:23712823
Abstract

OBJECTIVES

Oral healthcare expenses are increasing rapidly as a result of the growth of high-cost health technologies worldwide. In many developing/developed countries, low-cost tooth extraction is the alternative treatment option for a high-cost root canal therapy (RCT) for management of human molars with irreversible pulpitis. Vital pulp therapy with calcium-enriched mixture cement (VPT/CEM) as a new alternative treatment option has demonstrated excellent treatment outcomes up to 1 year; if 2-year radiographic/clinical effectiveness as well as cost-effectiveness of the VPT/CEM is also non-inferior compared with RCT, it can serve as a viable treatment for mature molars with irreversible pulpitis.

MATERIALS AND METHODS

In this prospective, multicenter (n = 23), non-inferiority clinical trial, 407 patients were randomized to either one-visit RCT (n = 202) or VPT/CEM (n = 205) for 27 months. In this part of study, the primary outcome measure was the 2-year clinical and radiographic treatment outcomes. Cost-effectiveness was also analyzed.

RESULTS

Mean follow-up times were 24.62 ± 0.72 and 24.61 ± 0.69 months in RCT (n = 166) and VPT/CEM (n = 166) arms, respectively. Clinical success rates in the two study arms were equal (98.19%); however, radiographic success rates were 79.5 and 86.7% in RCT and VPT/CEM arms, respectively, with no statistical difference (P = 0.053). The treatment time span mean was approximately three times greater in the RCT than in the VPT/CEM arm (94.07 vs. 31.09 min; P < 0.001). RCT had a cost of 171.5K per molar tooth compared with 44.5K for VPT.

CONCLUSIONS

VPT/CEM reduced time and cost spent. When considering clinical as well as cost-effectiveness of VPT/CEM, this treatment option is not only non-inferior but also superior to RCT in mature permanent molar teeth with established irreversible pulpitis.

CLINICAL RELEVANCE

Vital pulp therapy with CEM is a cost-effective and reliable biological technique for endodontic treatment of permanent molar teeth with irreversible pulpitis and can be recommended for general clinical practice.

摘要

目的

由于全球高成本医疗技术的发展,口腔医疗费用正在迅速增加。在许多发展中/发达国家,低成本拔牙是治疗患有不可逆性牙髓炎的人类磨牙的高成本根管治疗(RCT)的替代治疗选择。用富钙混合水泥进行活髓治疗(VPT/CEM)作为一种新的替代治疗选择,已显示出长达1年的优异治疗效果;如果VPT/CEM的2年影像学/临床有效性以及成本效益与RCT相比也不逊色,那么它可以作为患有不可逆性牙髓炎的成熟磨牙的可行治疗方法。

材料与方法

在这项前瞻性、多中心(n = 23)、非劣效性临床试验中,407名患者被随机分为单次就诊RCT组(n = 202)或VPT/CEM组(n = 205),为期27个月。在本研究的这一部分中,主要结局指标是2年的临床和影像学治疗结果。还分析了成本效益。

结果

RCT组(n = 166)和VPT/CEM组(n = 166)的平均随访时间分别为24.62±0.72个月和24.61±0.69个月。两个研究组的临床成功率相等(98.19%);然而,RCT组和VPT/CEM组的影像学成功率分别为79.5%和86.7%,无统计学差异(P = 0.053)。RCT组的治疗时间跨度平均比VPT/CEM组长约三倍(94.07分钟对31.09分钟;P < 0.001)。RCT每颗磨牙的成本为171.5K,而VPT为44.5K。

结论

VPT/CEM减少了时间和成本。考虑到VPT/CEM的临床和成本效益,这种治疗选择在患有已确诊不可逆性牙髓炎的成熟恒牙中不仅不逊色,而且优于RCT。

临床意义

用CEM进行活髓治疗是一种经济有效且可靠的生物学技术,用于治疗患有不可逆性牙髓炎的恒牙磨牙,可推荐用于一般临床实践。

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