Oral Health Intervention Program for Children With Congenital Heart Defects
Condition: Congenital Heart Defect; Dental Caries in Children; Dental Erosion; Dental Plaque; Hypomineralization, Tooth
MeSH terms: Dental Caries; Dental Plaque; Tooth Erosion; Dental Enamel Hypomineralization; Tooth Demineralization; Heart Defects, Congenital
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.

      Parental questionnaire and anamnestic factors:

      Parents of children in the intervention group were asked to respond to a questionnaire at
      baseline and at the second follow-up, while parents in the control group were asked at
      examination at age five years. The questionnaire contained 30 structured items. The topics
      covered were socio-demographic and anamnestic items, items about parental oral health
      attitudes, oral health related behaviours, and oral health promotion.The anamnestic
      background variables were coded cyanotic (1), not cyanotic (0), heart failure (1) and heart
      failure not present (0), taking heart medication (1) and does not take heart medication (0),
      low birth weight <2500 g (1) and normal birth weight >2500 g (0).

      Intervention At baseline (before three years) all parents in the intervention group received
      a standardised "knowledge package", included "Lift the lip program". Both general and local
      interventions were repeated at first follow-up at three years and second follow-up at five
      years. Risk assessment was made by the following background factors: 1) dental factors such
      as visible caries, visible plaque, gingivitis, erosion and DDE; 2) parental oral health
      related behaviours such as oral hygiene habits, dietary habits and use of fluoride; 3) social
      factors such as immigrant background where parents showed poor language skills; and 4)
      medical factors such as comorbidity and use of medication with drugs sweetened with sucrose.

      The recommendation from the caries risk assessment was the most intense preventive program
      for children with the highest caries risk (those children with the highest number of caries
      risk determinants). The children were evaluated based on data from the oral examination,
      anamnestic information and information obtained from the questionnaire and accordingly
      assigned to different promotive oral health intervention programs, denoted as Program I, II
      and III. As all the participants had CHD, stated previously as a risk for reduced oral
      Health, the most modest program applied was Program I. The children offered this program had
      no other known risk factors for poor oral health than CHD. Program II was assigned to
      children who had association with other known risk groups in terms of poor oral health or had
      signs of oral disease such as a) enamel caries grade1-2, erosion or DDE; b) findings from the
      questionnaire corresponding to additional risk for oral disease beyond what is normal for the
      group; c) immigrant background where parents show poor language skills and simultaneously
      caries lesions; and d) co-morbidities with additional risk for oral disease. Program III was
      assigned to children who also had other known risk determinants like very poor oral health,
      signs of severe oral disease or where findings from the questionnaire corresponded to serious
      risk of oral disease. After categorising the children to the various programs, each child's
      responsible dentist or dental hygienist at the local PDS clinic was contacted by telephone
      with information about the project and the findings of the examination. A written report with
      a treatment plan and recommendation for follow-up was sent after each oral examination: at
      baseline, first follow-up and second follow-up.

      The initial intervention plan for recommendations for the PDS dentists for follow-up of the
      highest risk children (Program III) included an option of recalls every month during a three
      month period. Compliance by the PDS staff with the recommendation for follow-up was evaluated
      when the second follow-up for all children was completed. The child's local PDS-clinic was
      contacted and feedback in the form of a written list of the child's appointments in the PDS
      in the period from baseline to the second follow-up was received. There was no information
      about clinical procedures undertaken, only dates of appointments.

      Statistical methods Descriptive statistics were used to characterise the intervention and the
      control group. The effectiveness of an early oral health intervention was estimated by
      comparing intervention and control groups on clinical oral health outcomes at age five years
      using a multiple logistic regression model for each outcome variable. The model was fitted
      unadjusted and adjusted for one of the following independent variables at a time: brushing
      habit, start age of tooth brushing, diet habit, parent's origin, parent's education,
      bottle-feeding, night meals, sugar water, sex, heart problems, cyanosis, birth weight, heart
      medication and syndrome.The various dependent dichotomised outcome variables for evaluating
      the effect of the intervention program were caries experience, dental erosion, PI and, GBI.
      The independent variables used in the logistic regression were selected in relation to known
      caries risk determinants and demographic background factors, which could influence the oral
      outcomes. In the final model, maximally adjustments were included to guarantee sufficient
      power. The adjustments with the largest deviation from odds ratio (OR) were selected in the
      unadjusted model if the deviation was at least 10% of the unadjusted OR. For other
      comparisons chi-square and independent sample t-test were used. The general significance
      level was set to 0.05. The Bonferroni correction was used to address multiple comparisons
      leading to the marginal significance levels of 0.0028 when comparing characteristics between
      the intervention and control group, and 0.01 for the logistic models. All analyses were
      performed using SPSS version 23 (Inc. Chicago, IL, USA) and Matlab 9.0 (Mathworks Inc.).
    

Intervention name(s): Oral health intervention program
Intervention type(s): Other
Intervention description(s): Intervention: 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.
Intervention model: Single Group Assignment
Intervention model description: Longitudinal study design, promoting oral health among children with congenital heart defects. Oral examination and intervention at baseline (below three years), at first follow-up (three years) and at second follow-up (five years).
Masking: None (Open Label)
Primary purpose: Prevention