Yengopal Veerasamy, Harneker Suyara Yasmin, Patel Naren, Siegfried Nandi
Department of Community Dentistry, School of Public Health, Division of Public Oral Health, Wits University, Private Bag 3, Wits, Johannesburg, South Africa, 2050.
Cochrane Database Syst Rev. 2009 Apr 15(2):CD004483. doi: 10.1002/14651858.CD004483.pub2.
Childhood caries (tooth decay) consists of a form of tooth decay that affects the milk teeth (also known as baby or primary teeth) of children. This may range from tooth decay in a single tooth to rampant caries affecting all the teeth in the mouth. Primary teeth in young children are vital to their development and every effort should be made to retain these teeth for as long as is possible. Dental fillings or restorations have been used as an intervention to repair these damaged teeth. Oral health professionals need to make astute decisions about the type of restorative (filling) material they choose to best manage their patients with childhood caries. This decision is by no means an easy one as remarkable advances in dental restorative materials over the last 10 years has seen the introduction of a multitude of different filling materials claiming to provide the best performance in terms of durability, aesthetics, symptom relief, etc when placed in the mouth. This review sought to compare the different types of dental materials against each other for the same outcomes.
The objective of this review was to compare the outcomes (including pain relief, survival and aesthetics) for restorative materials used to treat caries in the primary dentition in children. Additionally, the restoration of teeth was compared with extraction and no treatment.
Electronic searches of the following databases were undertaken: the Cochrane Oral Health Group's Trials Register (up to January 2009); CENTRAL (The Cochrane Library 2009, Issue1); MEDLINE (1966 to January 2009); EMBASE (1996 to January 2009); SIGLE (1976 to 2004); and conference proceedings on early childhood caries, restorative materials for paediatric dentistry, and material sciences conferences for dental materials used for children's dentistry (1990 to 2008). The searches attempted to identify all relevant studies irrespective of language.Additionally, the reference lists from articles of eligible papers were searched, handsearching of key journals was undertaken, and personal communication with authors and manufacturers of dental materials was initiated to increase the pool of suitable trials (both published and unpublished) for inclusion into this review.
Randomised controlled trials (RCTs) or quasi-randomised controlled trials with a minimum period of 6 months follow up were included. Both parallel group and split-mouth study designs were considered. The unit of randomisation could be the individual, group (school, school class, etc), tooth or tooth pair. Included studies had a drop-out rate of less than 30%. The eligible trials consisted of young children (children less than 12 years) with tooth decay involving at least one tooth in the primary dentition which was symptomatic or symptom free at the start of the study.
Data were independently extracted, in duplicate, by two review authors. Disagreements were resolved by consultation with a third review author. Authors were contacted for missing or unclear information regarding randomisation, allocation sequence, presentation of data, etc. A quality assessment of included trials was undertaken. The Cochrane Collaboration statistical guidelines were followed for data analysis.
Only three studies were included in this review. The Fuks 1999 study assessed the clinical performance of aesthetic crowns versus conventional stainless steel crowns in 11 children who had at least two mandibular primary molars that required a crown restoration. The outcomes assessed at 6 months included gingival health (odds ratio (OR) 0.3; 95% confidence interval (CI) 0.01 to 8.32), restoration failure (OR 3.29; 95% CI 0.12 to 89.81), occlusion, proximal contact and marginal integrity. The odds ratios for occlusion, proximal contact and marginal integrity could not be estimated as no events were recorded at the 6-month evaluation. The Donly 1999 split-mouth study compared a resin-modified glass ionomer (Vitremer) with amalgam over a 36-month period. Forty pairs of Class II restorations were placed in 40 patients (21 males; 19 females; mean age 8 years +/- 1.17; age range 6 to 9 years). Although the study period was 3 years (36 months), only the 6- and 12-month results are reported due to the loss to follow up of patients being greater than 30% for the 24- and 36-month data. Marks 1999a recruited 30 patients (age range 4 to 9 years; mean age 6.7 years, standard deviation 2.3) with one pair of primary molars that required a Class II restoration. The materials tested were Dyract (compomer) and Tytin (amalgam). Loss to follow up at 24 and 36 months was 20% and 43% respectively. This meant that only the 24-month data were useable. For all of the outcomes compared in all three studies, there were no significant differences in clinical performance between the materials tested.No studies were found that compared restorations versus extractions or no treatment as an intervention in children with childhood caries.
AUTHORS' CONCLUSIONS: It was disappointing that only three trials that compared three different types of materials were suitable for inclusion into this review. There were no significant differences found in all three trials for all of the outcomes assessed. Well designed, randomised controlled trials comparing the different types of filling materials for similar outcomes are urgently needed in dentistry. There was insufficient evidence from the three included trials to make any recommendations about which filling material to use.
儿童龋齿是一种影响儿童乳牙(也称为乳齿或乳牙)的龋齿形式。其范围可能从单个牙齿的龋齿到影响口腔中所有牙齿的猖獗龋齿。幼儿的乳牙对其发育至关重要,应尽一切努力尽可能长时间保留这些牙齿。牙科填充或修复已被用作修复这些受损牙齿的干预措施。口腔健康专业人员需要就他们选择的修复(填充)材料类型做出明智的决定,以便最好地治疗患有儿童龋齿的患者。由于过去10年牙科修复材料取得了显著进展,出现了多种不同的填充材料,声称在放入口腔时在耐久性、美观性、症状缓解等方面具有最佳性能,因此这一决定绝非易事。本综述旨在比较不同类型的牙科材料在相同结果方面的差异。
本综述的目的是比较用于治疗儿童乳牙列龋齿的修复材料的结果(包括疼痛缓解、存留率和美观性)。此外,还比较了牙齿修复与拔牙及不治疗的情况。
对以下数据库进行了电子检索:Cochrane口腔健康组试验注册库(截至2009年1月);CENTRAL(Cochrane图书馆2009年第1期);MEDLINE(1966年至2009年1月);EMBASE(1996年至2009年1月);SIGLE(1976年至2004年);以及关于幼儿龋齿、儿童牙科修复材料和儿童牙科用牙科材料的材料科学会议的会议记录(1990年至2008年)。检索试图识别所有相关研究,无论其语言如何。此外,还检索了符合条件论文的参考文献列表,对关键期刊进行了手工检索,并与牙科材料的作者和制造商进行了个人交流,以增加适合纳入本综述的试验(包括已发表和未发表的)数量。
纳入至少随访6个月的随机对照试验(RCT)或半随机对照试验。平行组和分口研究设计均予以考虑。随机化单位可以是个体、组(学校、班级等)、牙齿或牙齿对。纳入研究的失访率低于30%。符合条件的试验包括幼儿(12岁以下儿童),其乳牙列中至少有一颗牙齿有龋齿,在研究开始时有症状或无症状。
由两位综述作者独立、重复地提取数据。通过与第三位综述作者协商解决分歧。就随机化、分配序列、数据呈现等缺失或不清楚的信息与作者进行了联系。对纳入试验进行了质量评估。数据分析遵循Cochrane协作组织的统计指南。
本综述仅纳入了三项研究。Fuks 1999年的研究评估了11名至少有两颗下颌乳牙需要冠修复的儿童中,美观冠与传统不锈钢冠的临床性能。6个月时评估的结果包括牙龈健康(优势比(OR)0.3;95%置信区间(CI)0.01至8.32)、修复失败(OR 3.29;95%CI 0.12至89.81)、咬合、邻面接触和边缘完整性。由于在6个月评估时未记录任何事件,因此无法估计咬合、邻面接触和边缘完整性的优势比。Donly 1999年的分口研究在36个月期间比较了树脂改性玻璃离子水门汀(Vitremer)与汞合金。在40名患者(21名男性;19名女性;平均年龄8岁±1.17;年龄范围6至9岁)中放置了40对II类修复体。尽管研究期为3年(36个月),但由于24个月和36个月数据的患者失访率大于30%,因此仅报告了6个月和12个月的结果。Marks 1999a招募了30名患者(年龄范围4至9岁;平均年龄6.7岁,标准差2.3),他们有一对需要II类修复的乳牙。测试的材料是Dyract(复合体)和Tytin(汞合金)。24个月和36个月时的失访率分别为20%和43%。这意味着只有24个月的数据可用。在所有三项研究中比较的所有结果中,测试材料之间的临床性能没有显著差异。未发现有研究比较修复与拔牙或不治疗作为儿童龋齿干预措施的情况。
令人失望的是,本综述仅纳入了三项比较三种不同类型材料的试验。在所有三项试验中,所评估的所有结果均未发现显著差异。牙科迫切需要设计良好的随机对照试验,比较不同类型填充材料在类似结果方面的差异。纳入的三项试验证据不足,无法就使用哪种填充材料提出任何建议。