武汉市儿童龋病监测及防龋措施评估的相关临床研究
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摘要
研究背景：
本课题以武汉地区五所小学二年级学龄儿童为主要研究对象,对该人群乳牙患龋情况,龋病流行趋势,龋病转归,以及新生恒牙的预防措施的评估进行研究,为龋病防治以及防龋措施评估提供理论依据。本研究包含两个部分,第一部分是武汉地区二年级学龄儿童乳牙龋病流行趋势4年纵向观察和患龋乳牙3.5年转归的临床前瞻性观察的报告；第二部分是新生恒牙窝沟封闭评价方法的比较,包括使用临床检查,标准口内照以及石膏模型,对其评估窝沟封闭效果的一致性和准确性进行比较和验证。
课题的第一部分由两个口腔流行病学调查组成,龋病流行趋势,在整个世界范围内显示了不太一致的变化规律。自20世纪80年代以来,一些发达国家已经经历了稳步降低的患龋率,然而,在次发达国家的发展趋势尚不明朗。目前已经有许多针对调查学龄儿童患龋率的研究,在不同国家,城市,社区范围内都有展开。而我国儿童面临的最大口腔护理特点是,乳牙龋齿患病率相对较高。并且考虑到在过去的几十年里,经济稳步增长,幽国民消费能力提高,饮食结构的改变,监测龋齿的患病率和发病情况具有一定的必要性,特别是在儿童群体中。这一部分的第一个流行病学调查使用的是时滞-序列设计,研究在两个世代群体的儿童乳牙列四年间患龋率和患龋情况的变化趋势。另一方面,全国口腔健康调查的数据也显示了绝大多数乳牙龋齿未得到治疗由于口腔健康护力意识仍然比较落后,在儿童中定期检查牙齿仍然比较少见。本课题的第二部分是首次进行前瞻性临床随访,研究儿童患龋乳牙的转归过程,随访时间为3.5年。
窝沟封闭已被证明能够有效预防窝沟点隙处龋损的发生,专业人员应定期评估封闭剂的完整性和保存状况,以确保该措施防龋的有效性。2008年对武汉五所小学的二年级学龄儿童(患龋高风险)开展窝沟封闭预防龋病的临床课题,关于该课题两年的龋损预防效果已发表于相关论文上。该结果基于直视下的临床检查的方法。然而,由于临床检查具有以下的缺点,在长期的跟踪评估中,不可能重复,可能会引起较大的系统误差。但与直视下的临床检查法相比,间接的方法,如评估标准口内照片,X线片和样本的模型可减少这种系统误差因为这些间接的方法,允许同一检查时间的所有的样本,或者某一样本的不同的时间的状态在标准同一条件下被评估,同时不受检查者地域的限制。正因为间接评估方法有以上的优点,越来越多的运用于口腔临床流行病学的调查中。此外,还有可能增加临床工作者的效率,从而腾出资源,以改善现有的口腔护理状况,减少口腔健康资源的不平等。Golkari和Edelstein等使用标准口内照的方法对龋损和牙釉质发育缺陷的检出结果的可靠性进行了研究,发现该方法可靠性非常高。而评估样本模型的方法被认为在对磨耗相对较多的窝沟封闭剂的评估上更为敏感。然而,很少有研究同时比较和验证临床检查,标准口内照和样本模型的方法来评估窝沟封闭剂的保存状况以及继发龋损的检出能力。因此,在本课题的第二部分,就针对以上口的试图探寻在临床流行病学研究中评估封闭剂保存状况的最合适的方法。
第一部分：武汉地区二年级学龄儿童龋病监测及患龋乳牙转归的临床前瞻性观察研究
研究一：武汉地区二年级学龄儿童乳牙患龋情况4年纵向观察
目的：本研究的目的是为了检验这一研究假设,武汉地区二年级学龄儿童乳牙龋均,患龋率在4年内有所增加。菌斑软垢检出率提高。方法：采用时滞-序列的研究设计,分别于2007年和2011年对武汉地区5所小学二年级学龄儿童,采用ART龋齿检验标准和Greene&Vermillion的简化口腔卫生指数中的菌斑软垢计分方法进行龋病和菌斑软垢的临床检查。数据分析采用方差分析,t检验和卡方检验。结果：2007年991名儿童,2011年的1114名儿童受检。乳才患龋率有所下降：d3水平2007年68.3%,2011年为67.2%；d2水平上2007年78.5%,2001年为71%(p<0.001)。d3mft龋失补均在2007年为2.8,2011年为3.1(P=0.09),d3mfs龋失补面均在2007年为5.0,2011年为7.3(,<0.001)。d3t龋均比有所下降从2007年75%到2011年68%,而充填率有所提高,从2007年的21%增加到2011年的26%。研究假说不被接受。菌斑软垢检查结果显示,高计分(口腔卫生较差)的儿童的比率在2011年为21.8%,这个结果比2007年为5.7%有了大幅的增加。结论：目前还没有明显的迹象表明,武汉市二年级学龄儿童在2007年和2011年的乳牙患龋情况有所上升。但值得注意的是,平均患龋计分在牙面水平较高,菌斑软垢检出率增加,监测患龋率仍然是十分必要,类似研究应在比本研究人群更年幼的儿童中开展。卫生和教育部门应合作制定方案,旨在确保儿童良好的口腔卫生。
研究二：武汉地区二年级学龄儿童患龋乳牙转归临床前瞻性观察研究
目的：本研究是对武汉地区二年级学龄儿童患龋乳牙3.5年转归随访结果的报告。方法：作为相关窝沟封闭临床研究的对象,选择武汉地区五所小学具有高危龋病因素的儿童,对患龋乳牙病转归,进行前瞻性观察研究。患龋儿童及家长被告知应前往医院就医治疗患龋乳牙,对于随访6个月后仍然未得到治疗的患龋乳牙开始进行监测,记录儿童自我报告及随访检查结果,包括转归及症状(因龋导致的牙疼,脓肿或瘘管),间隔为每6个月,持续到该患牙自然脱落或者因龋拔除。数据分析采用方差分析和t检验。结果：随访共有来自于305名儿童(年均7.6-9.3岁)的1012未治疗的患龋乳牙,随访3.5年后共计92.9%的患龋乳牙仍未进行治疗,7.1%的患龋乳牙在随访某阶段被充填修复。98.5%的充填乳牙以及95.5%的未治疗乳牙,自然脱落。93.9%的充填乳牙和81.5%未治疗乳牙无任何症状脱落。牙疼是出现率最高的症状。充填乳牙生存时间比未治疗乳牙生存时间上有显著性差异1.99±0.07和1.68±0.03年(P=0.002)。结论：大部分随访患龋乳牙无症状自然脱落。
第二部分：武汉地区二年级学龄儿童恒牙窝沟封闭临床评估方法的研究
研究三：使用临床检查与石膏模型两种方法评估新生恒牙窝沟封闭两年保存效果
目的：比较采用临床检查和石膏模型两种方法评估不同窝沟封闭材料两年保存效果。方法：分别采用临床检查和石膏模型评估武汉地区307名二年级学龄儿童新生恒牙窝沟封闭后的材料保存状况。评估时间为窝沟封闭进行后第0.5,1.2年采用Kappa致性检验评估两种方法检出结果的一致性。评估封闭材料保存率采用传统和改良两种评价标准。Kaplan-Meier生存法统计封闭材料的累积保存率,采用Log-rank检验比较两种方法评估累积保存率结果(曲线)。结果：两种评估方法结果一致性的Kappa系数为0.36(传统评价标准)和0.38(改良评价标准)。采用石膏模型评估,可以检出更多的窝沟封闭材料。使用传统评价标准,石膏评估和临床检查得出两年累积保存率(曲线)结果有统计学差异(Log-rank,p=0.004),使用改良评价标准差异无统计学意义(Log-rank, p=0.47)。结论：采用石膏模型的间接评估方法在窝沟封闭两年后检出了更多的材料。
研究四：验证多种方法评估窝沟封闭保存效果的临床研究
目的：本研究的目的是为了检验这一研究假设,使用标准口内照比临床检查和石膏模型更能反映窝沟封闭材料保存的真实情况。方法：武汉地区二年级学龄儿童进行窝沟封闭两年后,部分学生进行封闭后的第一恒磨牙通过临床检查,标准口内照评估和石膏模型评估窝沟封闭材料的保存效果。评估封闭材料保存率采用传统和改良两种评估标准。并使用电镜照片的评估结果作为“金”标准,验证以上不同方法的评估结果。统计临床检查,样本石膏模型评估和标准口内照评估结果的结果一致性,敏感度和特异度,并计算各个方法的正确指数Youden index。结果：112颗窝沟封闭新生恒牙采用临床检查和标准口内照评估,43颗采用石膏模型进行评估,标准口内照评价的结果最接近金标准,其次为石膏模型,最后为临床检查结果。结论：标准口内照是比临床检查,石膏模型更能反映真实窝沟封闭材料保存效果的评价方法。
研究五：使用临床检查与标准彩照两种方法评估新生恒牙窝沟封闭四年封闭效果及继发龋损目的：本研究旨在比较使用临床检查与标准口内照两种方法评估新生恒牙窝沟封闭四年封闭效果及继发龋损结果的一致性。方法：两名检查者分别使用临床检查与标准口内照两种方法评估115颗新生恒牙窝沟封闭四年后材料的保存状况以及封闭牙面的继发龋损。采用Kappa一致性检验评估两种方法检出结果的一致性。评估封闭材料保存率采用传统和改良两种评估标准。结果：四年后样本窝沟封闭牙面继发龋损发生率过低,两名检查者使用两种评估方法检出继发龋损的一致性的Kappa系数为0.65(95%可信区间：0.65-0.74)和0.70(95%可信区间：0.62-0.78)：评估窝沟封闭材料保存一致性的Kappa系数为：0.71(95%可信区间：0.64-0.79)和0.80(95%可信区间：0.74-0.87),一位检查者使用标准口内照检出了更多的封闭材料。两名检查者使用标准口内照和临床检查检出样本的窝沟封闭保存率的结果,差异无显著性(传统和改良两种评估方法)。结论：使用临床检查与标准彩照两种方法评估新生恒牙四年窝沟封闭封闭效果以及继发龋损,标准口内照与临床检查的结果一致性较好,前者检出更多的窝沟封闭材料,但对于继发龋损的检出来说,本实验尚不能判断哪种方法更为可靠与准确。
Backgrounds:
This research was taken place in China, among school children of second grade students; the overall aim of this research was to monitor the caries prevalence and experience in primary dentitions, the natural course of cavitated primary dentitions and to investigate the most appropriate evaluation method for assessing sealant retention in newly erupted permanent molars over time.
The first part consisted of two epidemiological studies. Epidemiological studies of trends in dental caries prevalence have shown different patterns around the world. Several developed countries have experienced a steady reduction in dental caries prevalence since the1980s. However, trends in low-and middle-income countries are unclear. Studies covering dental caries in school children in various countries are numerous In China, children's need for dental care is characterized by the high prevalence of dental caries in primary dentition. Considering that over the past decades the economy in China has increased steadily, it is not unlikely to think that a cohort effect in caries prevalence might be present in the society of China. This warrants the necessity of monitoring the prevalence and severity of dental caries, particularly in young children. The first epidemiological study used a time-lag design to compare caries prevalence and caries experience in primary dentitions in two cohorts of children. Meanwhile, in China, dental-mindness is not much developed yet. Regular dental check-up visists are relatively rare. Data for China show96.7%of cavitated primary teeth among5-year-olds were left untreated. It is of interesting to investigate the natural course of the cavitated primary teeth within the Chinese health care system over time. And this was the aim of the second epidemiogical study.
Sealants have been shown to be effective in preventing the occurrence of the carious lesions in pits and fissures, and the integrity and retention of the sealant should be evaluated periodically, to ensure its effectiveness over time. In2008. a comparative sealant trial started in Wuhan, the results of the caries lesion preventive effects and sealant retention rates after2years have been published. Direct visual clinical examination was the method used for evaluation of the previous study. However, it is not possible to recall or reassess sealants after a while and it may introduce assessment bias in epidemiological studies. Compared to the direct method, indirect methods like colour photographs, radiographs and replica cause less observe bias. They further permit assessment for all cases under standard conditions by designated examiners whether it concerns cases from different geographic areas or if the same case is examined at different times. In addition, indirect methods have the potential to increase the efficiency and effectiveness of dentists working in the primary oral care environment, thereby freeing up resources to improve access to oral care and reduce oral health inequalities. Recently, the reliability of colour photographs in detecting developmental defects in enamel and in carious lesions have been investigated and found very reliable. And the replica method is regarding to be more sensitive in measuring the level of retention and degradation of dental sealants over time. However, few studies have compared and validate the visual clinical examination, replica method and the colour photographs with regard to sealant retention assessment over time. For this purpose, studies in this part were carried out and aimed to investigate the most appropriate evaluation method for assessing sealant retention.
Part I:Epidemiological Study:Surveillance on the primary dentition
Study1:Caries experience in primary dentitions and presence of plaque in two cohorts of children from an economically fast-growing country over a time lag of four years
Objectives. The aim of the present study was to test the hypothesis that dental caries prevalence and caries experience in primary dentitions has increased over4years and, to compare the presence of plaque in permanent teeth in child cohorts over4years. Methods:A time-lag study design was used comprising two cohorts of children aged6-8-years from the same5primary schools in Wuhan examined in2007and2011. Two calibrated examiners visually assessed the dentitions according to the ART caries criteria and plaque accumulation according to the Greene&Vermillion Index. ANOVA, t-test and Chi-Square test were used to test for differences between dependent and independent variables. Results:The2007-sample consisted of991and the2011-sample of1114children. The prevalence of dental caries (d3mft) was68.3%in2007and67.2%in2011, while that of d2mft was78.5%in2007and71%in2011(p<0.001). The mean d3mft score was2.8in2007and3.1in2011(p=0.09), while the mean d3mfs score was5.0in2007and7.3in2011(p<0.001). The d3-component of the d3mft index was75%in2007and68%in2011, while the f-component was21%in2007and26%in2011. The hypothesis was not accepted. The proportion of children with plaque code3(extensive coverage) was higher in2011(21.8%) than in age mates in2007(5.7%). Conclusions:There were no obvious signs that dental caries prevalence had been increased in primary dentitions of this child population between2007and2011. But as the mean caries experience scores at surface level were higher in2011than in2007, monitoring caries prevalence remains essential but should start at an earlier age than this study covered. Health and educational authorities should collaborate in setting up programmes aimed at ensuring good oral health for school children.
Study2:What happened to cavitated primary teeth over time? A3.5-year prospective cohort study in China.
Objectives:Data for China show that among5-year-olds96.7%of cavitated primary teeth were left untreated. The aim of this study is to report on the course of cavitated primary teeth within the Chinese healthcare system over an observational period of3.5years. Methods:Selection of high caries risk children for inclusion in a sealant comparison study was based on cavitated dentine lesion presence in their primary teeth. Although children had been advised to seek restorative care, at the6-month sealant evaluation point many of these cavitated dentine lesions had not been treated. This necessitated monitoring of these cavitated teeth, which was done every6months until exfoliation. In the course of this monitoring, exfoliated teeth, restored teeth, teeth with a cavity left open, those having caused toothache (symptom) and those having (had) an abscess or fistulae (symptom) were recorded. Care-seeking instruction was given at every evaluation point. The ANOVA, t-test and Kaplan-Meier survival method were used in analysing the data. Results:A total of1012cavitated primary teeth in305children ranging7.6-9.3years old, were followed for3.5years. A total of92.9%of the cavitated primary teeth were left open, while7.1%were restored at some stage during the observation period.98.5%of the restored and95.5%of cavitated teeth left open exfoliated.93.9%of restored teeth and81.5%of cavitated primary teeth left open exfoliated without any sign of a symptom. Having (had) toothache was the symptom most frequently related both to exfoliated restored teeth and to exfoliated cavitated teeth left open. Restored primary teeth survived statistically significantly longer than cavitated primary teeth left open:1.99±0.07years and1.68±0.03years, respectively. Conclusion:The large majority of cavitated primary teeth in this child population exfoliated without symptoms.
Part Ⅱ:Clinical trial:Evaluation of Sealant assessment methods
Study3:Comparison between visual clinical examination and replica method assessments of sealant retention over a2year period
Objectives:To compare the level of agreement and the survival rate of sealant retention of different sealing materials over a period of two years assessed according to the visual clinical examination and the replica method.Methods:Sealant retention data were obtained from clinical examination and replicas from one and the same sealed tooth at baseline and at0.5.1and2years evaluation points of307children, and compared for agreement using kappa-coefficients. Survival curves of retained sealants in occlusal surfaces were performed using the traditional categorization (fully and partially retained versus completely lost sealants) and the modified categorization (fully and partially retained versus completely lost sealants including those pits and fissures that had≥1pit re-exposed) according to the Kaplan-Meijer method. Results: The kappa-coefficients for the agreement test between both assessment method over the combined three evaluation points was0.36for the traditional and0.38for the modified categorization of retention. More sealant retention was observed from replicas than through visual clinical examination according to both categorizations of determining retention. For the traditional categorization, cumulative survival curves for the three times of evaluation were statistically significantly higher when assessed from replicas (p=0.004) but not according to the modified categorization (p=0.47). Significance:More retained sealant material was observed using the replica method than through the visible clinical examination during the two year evaluation period. The modified categorization of determining partial retention and completely lost sealant material appears to be more appropriate for calculating the survival rate of sealant retention than the traditional manner.
Study4:Validation of three different methods for assessing sealant retention
Objective:To test the hypothesis that the color photograph method has a higher level of validity for assessing sealant retention than those obtained from the visual clinical examination and replica methods.Methods:From a sample of sealed1st molars, retention was assessed according to the visual clinical examination and from colour photographs by the same two evaluators, and from replicas by two other evaluators. Scores of the three methods were compared against consensus scores derived from assessing retention from SEM images (gold standard). Presence or absence (survival) of retained sealants in occlusal surfaces was determined according to the traditional categorization (fully and partially retained versus completely lost sealants) and to the modified categorization (fully retained and those having≥1pit covered with the sealant material versus completely lost sealants, that included those pits and fissures that had≥1pit re-exposed). Percentage of agreement, sensitivity, specificity and Youden-index scores were calculated. Results:Kappa-coefficients for inter-consistency reliability of data obtained from the three methods were high/substantial. Comparing sealant retention assessment scores of visual clinical examinations and colour photographs with those of the SEM images was performed on112teeth for replicas on43teeth. The highest mean Youden-index score for presence/absence of sealant material was observed for the colour photograph method, followed by that of the replica method whilst the visual clinical examination method scored lowest. The mean Youden-index score for the survival of retained sealants was highest for the colour photograph method for both the traditional (0.867) and the modified (0.747) category of determining sealant retention, with the visual clinical examination method having the lowest Younden-index score (0.730-0.053). Conclusions:Assessing sealant retention from colour photographs appears to be a valid method while the visual clinical examination appears not to be a valid method anymore.
Study5:Detecting carious lesions and assessing sealant retention through visual clinical examination and from colour photographs after4years
Objective:To compare the level of agreement of carious lesion development and that of sealant retention as assessed according to the visual clinical examination and the colour photograph methods. Methods; Data from retained sealant and presence of carious lesions were obtained from visual clinical examination and from colour photographs from the same sealed teeth after4-years by two examiners. Kappa-statistics were applied to calculate agreement. Survival rates of retained sealants in occlusal surfaces were estimated, using the traditional (completely gone versus fully and partially retained sealants) and the modified categorization (completely gone sealants, which included pits and fissures system that had≥1pit re-exposed, versus fully retained and partially retained sealants). Results:The prevalence of dentine carious lesions was too low. The kappa-coefficients for detecting carious lesions for both assessment methods by the two examiners were0.65(CI:0.56-0.74) and0.70(CI:0.62-0.78) and they were0.71(CI:0.64-0.79) and0.80(CI:0.74-0.87) for assessing sealant retention. Survival rates of retained sealants between the visual clinical examination and the colour photograph methods for both types of categorization were not statistically significantly different. Conclusion:The colour photograph method is not different in detecting carious lesions but appears more sensitive in assessing sealant retention than the visual clinical examination after4years.
本课题以武汉地区五所小学二年级学龄儿童为主要研究对象,对该人群乳牙患龋情况,龋病流行趋势,龋病转归,以及新生恒牙的预防措施的评估进行研究,为龋病防治以及防龋措施评估提供理论依据。本研究包含两个部分,第一部分是武汉地区二年级学龄儿童乳牙龋病流行趋势4年纵向观察和患龋乳牙3.5年转归的临床前瞻性观察的报告；第二部分是新生恒牙窝沟封闭评价方法的比较,包括使用临床检查,标准口内照以及石膏模型,对其评估窝沟封闭效果的一致性和准确性进行比较和验证。
课题的第一部分由两个口腔流行病学调查组成,龋病流行趋势,在整个世界范围内显示了不太一致的变化规律。自20世纪80年代以来,一些发达国家已经经历了稳步降低的患龋率,然而,在次发达国家的发展趋势尚不明朗。目前已经有许多针对调查学龄儿童患龋率的研究,在不同国家,城市,社区范围内都有展开。而我国儿童面临的最大口腔护理特点是,乳牙龋齿患病率相对较高。并且考虑到在过去的几十年里,经济稳步增长,幽国民消费能力提高,饮食结构的改变,监测龋齿的患病率和发病情况具有一定的必要性,特别是在儿童群体中。这一部分的第一个流行病学调查使用的是时滞-序列设计,研究在两个世代群体的儿童乳牙列四年间患龋率和患龋情况的变化趋势。另一方面,全国口腔健康调查的数据也显示了绝大多数乳牙龋齿未得到治疗由于口腔健康护力意识仍然比较落后,在儿童中定期检查牙齿仍然比较少见。本课题的第二部分是首次进行前瞻性临床随访,研究儿童患龋乳牙的转归过程,随访时间为3.5年。
窝沟封闭已被证明能够有效预防窝沟点隙处龋损的发生,专业人员应定期评估封闭剂的完整性和保存状况,以确保该措施防龋的有效性。2008年对武汉五所小学的二年级学龄儿童(患龋高风险)开展窝沟封闭预防龋病的临床课题,关于该课题两年的龋损预防效果已发表于相关论文上。该结果基于直视下的临床检查的方法。然而,由于临床检查具有以下的缺点,在长期的跟踪评估中,不可能重复,可能会引起较大的系统误差。但与直视下的临床检查法相比,间接的方法,如评估标准口内照片,X线片和样本的模型可减少这种系统误差因为这些间接的方法,允许同一检查时间的所有的样本,或者某一样本的不同的时间的状态在标准同一条件下被评估,同时不受检查者地域的限制。正因为间接评估方法有以上的优点,越来越多的运用于口腔临床流行病学的调查中。此外,还有可能增加临床工作者的效率,从而腾出资源,以改善现有的口腔护理状况,减少口腔健康资源的不平等。Golkari和Edelstein等使用标准口内照的方法对龋损和牙釉质发育缺陷的检出结果的可靠性进行了研究,发现该方法可靠性非常高。而评估样本模型的方法被认为在对磨耗相对较多的窝沟封闭剂的评估上更为敏感。然而,很少有研究同时比较和验证临床检查,标准口内照和样本模型的方法来评估窝沟封闭剂的保存状况以及继发龋损的检出能力。因此,在本课题的第二部分,就针对以上口的试图探寻在临床流行病学研究中评估封闭剂保存状况的最合适的方法。
第一部分：武汉地区二年级学龄儿童龋病监测及患龋乳牙转归的临床前瞻性观察研究
研究一：武汉地区二年级学龄儿童乳牙患龋情况4年纵向观察
目的：本研究的目的是为了检验这一研究假设,武汉地区二年级学龄儿童乳牙龋均,患龋率在4年内有所增加。菌斑软垢检出率提高。方法：采用时滞-序列的研究设计,分别于2007年和2011年对武汉地区5所小学二年级学龄儿童,采用ART龋齿检验标准和Greene&Vermillion的简化口腔卫生指数中的菌斑软垢计分方法进行龋病和菌斑软垢的临床检查。数据分析采用方差分析,t检验和卡方检验。结果：2007年991名儿童,2011年的1114名儿童受检。乳才患龋率有所下降：d3水平2007年68.3%,2011年为67.2%；d2水平上2007年78.5%,2001年为71%(p<0.001)。d3mft龋失补均在2007年为2.8,2011年为3.1(P=0.09),d3mfs龋失补面均在2007年为5.0,2011年为7.3(,<0.001)。d3t龋均比有所下降从2007年75%到2011年68%,而充填率有所提高,从2007年的21%增加到2011年的26%。研究假说不被接受。菌斑软垢检查结果显示,高计分(口腔卫生较差)的儿童的比率在2011年为21.8%,这个结果比2007年为5.7%有了大幅的增加。结论：目前还没有明显的迹象表明,武汉市二年级学龄儿童在2007年和2011年的乳牙患龋情况有所上升。但值得注意的是,平均患龋计分在牙面水平较高,菌斑软垢检出率增加,监测患龋率仍然是十分必要,类似研究应在比本研究人群更年幼的儿童中开展。卫生和教育部门应合作制定方案,旨在确保儿童良好的口腔卫生。
研究二：武汉地区二年级学龄儿童患龋乳牙转归临床前瞻性观察研究
目的：本研究是对武汉地区二年级学龄儿童患龋乳牙3.5年转归随访结果的报告。方法：作为相关窝沟封闭临床研究的对象,选择武汉地区五所小学具有高危龋病因素的儿童,对患龋乳牙病转归,进行前瞻性观察研究。患龋儿童及家长被告知应前往医院就医治疗患龋乳牙,对于随访6个月后仍然未得到治疗的患龋乳牙开始进行监测,记录儿童自我报告及随访检查结果,包括转归及症状(因龋导致的牙疼,脓肿或瘘管),间隔为每6个月,持续到该患牙自然脱落或者因龋拔除。数据分析采用方差分析和t检验。结果：随访共有来自于305名儿童(年均7.6-9.3岁)的1012未治疗的患龋乳牙,随访3.5年后共计92.9%的患龋乳牙仍未进行治疗,7.1%的患龋乳牙在随访某阶段被充填修复。98.5%的充填乳牙以及95.5%的未治疗乳牙,自然脱落。93.9%的充填乳牙和81.5%未治疗乳牙无任何症状脱落。牙疼是出现率最高的症状。充填乳牙生存时间比未治疗乳牙生存时间上有显著性差异1.99±0.07和1.68±0.03年(P=0.002)。结论：大部分随访患龋乳牙无症状自然脱落。
第二部分：武汉地区二年级学龄儿童恒牙窝沟封闭临床评估方法的研究
研究三：使用临床检查与石膏模型两种方法评估新生恒牙窝沟封闭两年保存效果
目的：比较采用临床检查和石膏模型两种方法评估不同窝沟封闭材料两年保存效果。方法：分别采用临床检查和石膏模型评估武汉地区307名二年级学龄儿童新生恒牙窝沟封闭后的材料保存状况。评估时间为窝沟封闭进行后第0.5,1.2年采用Kappa致性检验评估两种方法检出结果的一致性。评估封闭材料保存率采用传统和改良两种评价标准。Kaplan-Meier生存法统计封闭材料的累积保存率,采用Log-rank检验比较两种方法评估累积保存率结果(曲线)。结果：两种评估方法结果一致性的Kappa系数为0.36(传统评价标准)和0.38(改良评价标准)。采用石膏模型评估,可以检出更多的窝沟封闭材料。使用传统评价标准,石膏评估和临床检查得出两年累积保存率(曲线)结果有统计学差异(Log-rank,p=0.004),使用改良评价标准差异无统计学意义(Log-rank, p=0.47)。结论：采用石膏模型的间接评估方法在窝沟封闭两年后检出了更多的材料。
研究四：验证多种方法评估窝沟封闭保存效果的临床研究
目的：本研究的目的是为了检验这一研究假设,使用标准口内照比临床检查和石膏模型更能反映窝沟封闭材料保存的真实情况。方法：武汉地区二年级学龄儿童进行窝沟封闭两年后,部分学生进行封闭后的第一恒磨牙通过临床检查,标准口内照评估和石膏模型评估窝沟封闭材料的保存效果。评估封闭材料保存率采用传统和改良两种评估标准。并使用电镜照片的评估结果作为“金”标准,验证以上不同方法的评估结果。统计临床检查,样本石膏模型评估和标准口内照评估结果的结果一致性,敏感度和特异度,并计算各个方法的正确指数Youden index。结果：112颗窝沟封闭新生恒牙采用临床检查和标准口内照评估,43颗采用石膏模型进行评估,标准口内照评价的结果最接近金标准,其次为石膏模型,最后为临床检查结果。结论：标准口内照是比临床检查,石膏模型更能反映真实窝沟封闭材料保存效果的评价方法。
研究五：使用临床检查与标准彩照两种方法评估新生恒牙窝沟封闭四年封闭效果及继发龋损目的：本研究旨在比较使用临床检查与标准口内照两种方法评估新生恒牙窝沟封闭四年封闭效果及继发龋损结果的一致性。方法：两名检查者分别使用临床检查与标准口内照两种方法评估115颗新生恒牙窝沟封闭四年后材料的保存状况以及封闭牙面的继发龋损。采用Kappa一致性检验评估两种方法检出结果的一致性。评估封闭材料保存率采用传统和改良两种评估标准。结果：四年后样本窝沟封闭牙面继发龋损发生率过低,两名检查者使用两种评估方法检出继发龋损的一致性的Kappa系数为0.65(95%可信区间：0.65-0.74)和0.70(95%可信区间：0.62-0.78)：评估窝沟封闭材料保存一致性的Kappa系数为：0.71(95%可信区间：0.64-0.79)和0.80(95%可信区间：0.74-0.87),一位检查者使用标准口内照检出了更多的封闭材料。两名检查者使用标准口内照和临床检查检出样本的窝沟封闭保存率的结果,差异无显著性(传统和改良两种评估方法)。结论：使用临床检查与标准彩照两种方法评估新生恒牙四年窝沟封闭封闭效果以及继发龋损,标准口内照与临床检查的结果一致性较好,前者检出更多的窝沟封闭材料,但对于继发龋损的检出来说,本实验尚不能判断哪种方法更为可靠与准确。
Backgrounds:
This research was taken place in China, among school children of second grade students; the overall aim of this research was to monitor the caries prevalence and experience in primary dentitions, the natural course of cavitated primary dentitions and to investigate the most appropriate evaluation method for assessing sealant retention in newly erupted permanent molars over time.
The first part consisted of two epidemiological studies. Epidemiological studies of trends in dental caries prevalence have shown different patterns around the world. Several developed countries have experienced a steady reduction in dental caries prevalence since the1980s. However, trends in low-and middle-income countries are unclear. Studies covering dental caries in school children in various countries are numerous In China, children's need for dental care is characterized by the high prevalence of dental caries in primary dentition. Considering that over the past decades the economy in China has increased steadily, it is not unlikely to think that a cohort effect in caries prevalence might be present in the society of China. This warrants the necessity of monitoring the prevalence and severity of dental caries, particularly in young children. The first epidemiological study used a time-lag design to compare caries prevalence and caries experience in primary dentitions in two cohorts of children. Meanwhile, in China, dental-mindness is not much developed yet. Regular dental check-up visists are relatively rare. Data for China show96.7%of cavitated primary teeth among5-year-olds were left untreated. It is of interesting to investigate the natural course of the cavitated primary teeth within the Chinese health care system over time. And this was the aim of the second epidemiogical study.
Sealants have been shown to be effective in preventing the occurrence of the carious lesions in pits and fissures, and the integrity and retention of the sealant should be evaluated periodically, to ensure its effectiveness over time. In2008. a comparative sealant trial started in Wuhan, the results of the caries lesion preventive effects and sealant retention rates after2years have been published. Direct visual clinical examination was the method used for evaluation of the previous study. However, it is not possible to recall or reassess sealants after a while and it may introduce assessment bias in epidemiological studies. Compared to the direct method, indirect methods like colour photographs, radiographs and replica cause less observe bias. They further permit assessment for all cases under standard conditions by designated examiners whether it concerns cases from different geographic areas or if the same case is examined at different times. In addition, indirect methods have the potential to increase the efficiency and effectiveness of dentists working in the primary oral care environment, thereby freeing up resources to improve access to oral care and reduce oral health inequalities. Recently, the reliability of colour photographs in detecting developmental defects in enamel and in carious lesions have been investigated and found very reliable. And the replica method is regarding to be more sensitive in measuring the level of retention and degradation of dental sealants over time. However, few studies have compared and validate the visual clinical examination, replica method and the colour photographs with regard to sealant retention assessment over time. For this purpose, studies in this part were carried out and aimed to investigate the most appropriate evaluation method for assessing sealant retention.
Part I:Epidemiological Study:Surveillance on the primary dentition
Study1:Caries experience in primary dentitions and presence of plaque in two cohorts of children from an economically fast-growing country over a time lag of four years
Objectives. The aim of the present study was to test the hypothesis that dental caries prevalence and caries experience in primary dentitions has increased over4years and, to compare the presence of plaque in permanent teeth in child cohorts over4years. Methods:A time-lag study design was used comprising two cohorts of children aged6-8-years from the same5primary schools in Wuhan examined in2007and2011. Two calibrated examiners visually assessed the dentitions according to the ART caries criteria and plaque accumulation according to the Greene&Vermillion Index. ANOVA, t-test and Chi-Square test were used to test for differences between dependent and independent variables. Results:The2007-sample consisted of991and the2011-sample of1114children. The prevalence of dental caries (d3mft) was68.3%in2007and67.2%in2011, while that of d2mft was78.5%in2007and71%in2011(p<0.001). The mean d3mft score was2.8in2007and3.1in2011(p=0.09), while the mean d3mfs score was5.0in2007and7.3in2011(p<0.001). The d3-component of the d3mft index was75%in2007and68%in2011, while the f-component was21%in2007and26%in2011. The hypothesis was not accepted. The proportion of children with plaque code3(extensive coverage) was higher in2011(21.8%) than in age mates in2007(5.7%). Conclusions:There were no obvious signs that dental caries prevalence had been increased in primary dentitions of this child population between2007and2011. But as the mean caries experience scores at surface level were higher in2011than in2007, monitoring caries prevalence remains essential but should start at an earlier age than this study covered. Health and educational authorities should collaborate in setting up programmes aimed at ensuring good oral health for school children.
Study2:What happened to cavitated primary teeth over time? A3.5-year prospective cohort study in China.
Objectives:Data for China show that among5-year-olds96.7%of cavitated primary teeth were left untreated. The aim of this study is to report on the course of cavitated primary teeth within the Chinese healthcare system over an observational period of3.5years. Methods:Selection of high caries risk children for inclusion in a sealant comparison study was based on cavitated dentine lesion presence in their primary teeth. Although children had been advised to seek restorative care, at the6-month sealant evaluation point many of these cavitated dentine lesions had not been treated. This necessitated monitoring of these cavitated teeth, which was done every6months until exfoliation. In the course of this monitoring, exfoliated teeth, restored teeth, teeth with a cavity left open, those having caused toothache (symptom) and those having (had) an abscess or fistulae (symptom) were recorded. Care-seeking instruction was given at every evaluation point. The ANOVA, t-test and Kaplan-Meier survival method were used in analysing the data. Results:A total of1012cavitated primary teeth in305children ranging7.6-9.3years old, were followed for3.5years. A total of92.9%of the cavitated primary teeth were left open, while7.1%were restored at some stage during the observation period.98.5%of the restored and95.5%of cavitated teeth left open exfoliated.93.9%of restored teeth and81.5%of cavitated primary teeth left open exfoliated without any sign of a symptom. Having (had) toothache was the symptom most frequently related both to exfoliated restored teeth and to exfoliated cavitated teeth left open. Restored primary teeth survived statistically significantly longer than cavitated primary teeth left open:1.99±0.07years and1.68±0.03years, respectively. Conclusion:The large majority of cavitated primary teeth in this child population exfoliated without symptoms.
Part Ⅱ:Clinical trial:Evaluation of Sealant assessment methods
Study3:Comparison between visual clinical examination and replica method assessments of sealant retention over a2year period
Objectives:To compare the level of agreement and the survival rate of sealant retention of different sealing materials over a period of two years assessed according to the visual clinical examination and the replica method.Methods:Sealant retention data were obtained from clinical examination and replicas from one and the same sealed tooth at baseline and at0.5.1and2years evaluation points of307children, and compared for agreement using kappa-coefficients. Survival curves of retained sealants in occlusal surfaces were performed using the traditional categorization (fully and partially retained versus completely lost sealants) and the modified categorization (fully and partially retained versus completely lost sealants including those pits and fissures that had≥1pit re-exposed) according to the Kaplan-Meijer method. Results: The kappa-coefficients for the agreement test between both assessment method over the combined three evaluation points was0.36for the traditional and0.38for the modified categorization of retention. More sealant retention was observed from replicas than through visual clinical examination according to both categorizations of determining retention. For the traditional categorization, cumulative survival curves for the three times of evaluation were statistically significantly higher when assessed from replicas (p=0.004) but not according to the modified categorization (p=0.47). Significance:More retained sealant material was observed using the replica method than through the visible clinical examination during the two year evaluation period. The modified categorization of determining partial retention and completely lost sealant material appears to be more appropriate for calculating the survival rate of sealant retention than the traditional manner.
Study4:Validation of three different methods for assessing sealant retention
Objective:To test the hypothesis that the color photograph method has a higher level of validity for assessing sealant retention than those obtained from the visual clinical examination and replica methods.Methods:From a sample of sealed1st molars, retention was assessed according to the visual clinical examination and from colour photographs by the same two evaluators, and from replicas by two other evaluators. Scores of the three methods were compared against consensus scores derived from assessing retention from SEM images (gold standard). Presence or absence (survival) of retained sealants in occlusal surfaces was determined according to the traditional categorization (fully and partially retained versus completely lost sealants) and to the modified categorization (fully retained and those having≥1pit covered with the sealant material versus completely lost sealants, that included those pits and fissures that had≥1pit re-exposed). Percentage of agreement, sensitivity, specificity and Youden-index scores were calculated. Results:Kappa-coefficients for inter-consistency reliability of data obtained from the three methods were high/substantial. Comparing sealant retention assessment scores of visual clinical examinations and colour photographs with those of the SEM images was performed on112teeth for replicas on43teeth. The highest mean Youden-index score for presence/absence of sealant material was observed for the colour photograph method, followed by that of the replica method whilst the visual clinical examination method scored lowest. The mean Youden-index score for the survival of retained sealants was highest for the colour photograph method for both the traditional (0.867) and the modified (0.747) category of determining sealant retention, with the visual clinical examination method having the lowest Younden-index score (0.730-0.053). Conclusions:Assessing sealant retention from colour photographs appears to be a valid method while the visual clinical examination appears not to be a valid method anymore.
Study5:Detecting carious lesions and assessing sealant retention through visual clinical examination and from colour photographs after4years
Objective:To compare the level of agreement of carious lesion development and that of sealant retention as assessed according to the visual clinical examination and the colour photograph methods. Methods; Data from retained sealant and presence of carious lesions were obtained from visual clinical examination and from colour photographs from the same sealed teeth after4-years by two examiners. Kappa-statistics were applied to calculate agreement. Survival rates of retained sealants in occlusal surfaces were estimated, using the traditional (completely gone versus fully and partially retained sealants) and the modified categorization (completely gone sealants, which included pits and fissures system that had≥1pit re-exposed, versus fully retained and partially retained sealants). Results:The prevalence of dentine carious lesions was too low. The kappa-coefficients for detecting carious lesions for both assessment methods by the two examiners were0.65(CI:0.56-0.74) and0.70(CI:0.62-0.78) and they were0.71(CI:0.64-0.79) and0.80(CI:0.74-0.87) for assessing sealant retention. Survival rates of retained sealants between the visual clinical examination and the colour photograph methods for both types of categorization were not statistically significantly different. Conclusion:The colour photograph method is not different in detecting carious lesions but appears more sensitive in assessing sealant retention than the visual clinical examination after4years.
引文
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