Evaluation of an Oral Health Intervention Program for Children With Congenital Heart Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Dental caries
研究概览
简要总结
Background: Children with congenital heart defects (CHD) are reported to have poorer oral health compared with healthy children. The aim of the present study was to evaluate the effect of an intensive oral health care program among children with CHD followed from infancy to the age of five years, by comparing their oral health status at five years with a control group of children with CHD who had not received the program.
Methods: In this longitudinal study, children in western Norway with a need for lifelong follow-up due to congenital heart defects were invited to participate (n=119). Children born in 2008-2011 were offered a promotive oral health intervention program from infancy to the age of five years. The outcome measures for evaluating the intervention were dental caries prevalence, dental erosion, plaque index and gingival bleeding index. The data of the intervention group were compared with cross sectional oral health data of five year old controls with CHD born 2005-2007 (already published).
详细描述
This was a prospective longitudinal design study, including four cohorts of children with CHD (born 2008-2011) who required lifelong follow-up for their CHD. Parents, who did not respond to the initial letter of invitation for their child, received a reminder by mail two months later. All children in the intervention group were recruited before three years of age. A total of 119 children (66 girls) were invited to participate and receive an oral health intervention; at baseline (below three years), at first follow-up (three years) and at second follow-up (five years). Because parents were responsible for their young children's oral health, we found no reason to exclude children with co-morbidities such as Down's syndrome, Di George syndrome, Noonan syndrome, Cornelia de Lange syndrome, Williams's syndrome and autism. According to their CHD, the children were divided in three groups; i) left-to-right shunts, e.g. atrial septal defect and ventricular septal defect, ii) obstructions, e.g. coarctation of the aorta, aortic stenosis, and pulmonary stenosis, and iii) complex heart defects, e.g. tetralogy of Fallots, transposition of the great arteries and hypoplastic left or right heart syndromes. At five years, data on oral health and oral health related background factors were compared with corresponding published data of 5-year-old children with CHD, also from Western Norway (n=67, born 2005-2007). The latter group served as controls. These children were recruited at the age of five years and had not been offered the intensive oral health intervention program received by children in the intervention group. The control group had been followed in the PDS in line with the general population of children, who are offered the first oral examination from three years of age.
The caries prevalence (at dentine level) of five year olds in the control group had previously been compared with the corresponding prevalence of five year olds in the general population from the national health register "KOSTRA" (Municipality-State-Report of 2010, 2011 and 2012 in three counties in Western Norway, n = 18,974). Likewise the caries prevalence at age five years of the present intervention group were compared with the general population (Municipality-State-Report of 2013, 2014, 2015, 2016, n=26161). Possible time trends in caries epidemiology of five year olds during 2010-2016 were assessed.
Children's clinical oral examinations:
At baseline (below three years of age) a simplified oral examination was performed. Children were examined sitting on their parents' laps in the dental chair or on a regular chair examined by the "lap to lap" method. At the first follow-up examination at three years old, the children sat either on parents' laps or alone in the dental chair. Procedures for the oral health examination of the intervention and of the control group at five years of age were the same. Examinations were performed using a mouth mirror and a dental probe under good lighting conditions. Caries and DDE were registered for all dental surfaces while index teeth were used for dental erosion, dental plaque and gingival bleeding. Bitewing radiographs (BW) were only taken in five year olds, when there were molar contacts. Parents with immigrant background were offered interpreting services if desired. All oral health examinations were conducted by the same two dentists who previously had collected the published inter- and intra-observer reliability data of the control group.
Criteria for the various diagnostic systems were as follows: For caries, a five-graded diagnostic system was used,where enamel lesions were characterised as grades 1 or 2, and dentine lesions as grades 3, 4, or 5. Secondary caries, filled and extracted (due to caries only) teeth and the care index (a fraction with filled teeth as numerator and d3-5mft count as denominator). For dental erosion, a four graded diagnostic system was applied on buccal and palatal surfaces of the primary maxillary anterior teeth (53-63) and the occlusal surfaces of all primary molars. Erosion grade 3 was considered severe and grade 4 very severe. A modified DDE index was selected for DDE registration in which demarcated opacities were coded 1, diffuse opacities 2, demarcated and diffuse opacities 3, hypoplasia 4, hypoplasia and opacities 5, post-eruptive breakdown of enamel 6, and atypical fillings 7. Finally, for dental plaque and gingival bleeding, the PI and GBI were reported around the marker teeth 55, 51, 65, 75, 71, and 85. The presence of plaque in the four amelo-gingival areas was assessed with a dental probe and absence of debris was recorded as score 0 and presence as score 1. Gingival bleeding was recorded by probing cautiously using a WHO periodontal probe with a 0.5-mm ball tip on six surfaces; mesio-buccal, in the middle of the buccal surface, disto-buccal, mesio-lingual, in the middle of the lingual surface and, disto-lingual. If bleeding occurred within 10 seconds in at least one of the places, the tooth was scored 1 (bleeding), otherwise the tooth was scored 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 76 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with congenital heart defects (CHD) in western Norway, born 2008-2011 who require lifelong follow-up for their CHD.
排除标准
- 未提供
研究组 & 干预措施
Oral health intervention program
Oral Health intervention program: All parents were encouraged to brush their children's teeth twice a day, with adjusted amount of fluoride toothpaste according to age. Additional fluoride tablets with dose according to age were recommended from two years of age. The children's parents were given written information about the importance and benefits of optimal oral hygiene and explaining the link to infective endocarditis. A pamphlet, lift the lip program, with instruction of looking for early signs of tooth decay, how to intervene and contact local Public Dental Service (PDS) clinic. Dietary advice was also given. The child's responsible dentist or dental hygienist at the local PDS was contacted with information about the project and the findings from examination.
干预措施: Oral health intervention program (Other)
结局指标
主要结局
Dental caries
时间窗: Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).
Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was dental caries.Caries in the individual is measured as "caries experience" and quantified with decayed, missing or filled teeth (dmft). At the group level, caries prevalence is the proportion of a group that has any level of caries (dmft\> 0).
Gingival bleeding
时间窗: Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).
Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was gingival bleeding index (GBI).Gingival bleeding was recorded around the marker teeth 55, 51, 65, 75, 71, and 85 by probing cautiously using a WHO periodontal probe with a 0.5-mm ball tip on six surfaces; mesio-buccal, in the middle of the buccal surface, disto-buccal, mesio-lingual, in the middle of the lingual surface and, disto-lingual. If bleeding occurred within 10 seconds in at least one of the places, the tooth was scored 1 (bleeding), otherwise the tooth was scored 0.
Dental erosion
时间窗: Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).
Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was dental erosion.For dental erosion, a four graded diagnostic system was applied on buccal and palatal surfaces of the primary maxillary anterior teeth (53-63) and the occlusal surfaces of all primary molars. Erosion grade 3 was considered severe and grade 4 very severe. Prevalence of dental erosion close to or into the dentine ( grade 3-4) was the outcome measurement.
Dental plaque
时间窗: Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).
Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was plaque index.For dental plaque the plaque index was reported around the marker teeth 55, 51, 65, 75, 71, and 85. The presence of plaque in the four amelo-gingival areas was assessed with a dental probe and absence of debris was recorded as score 0 and presence as score 1.
次要结局
未报告次要终点
