Dental Caries Clinical Trial
Official title:
Perceived Impact of Dental Pain on the Quality of Life of Preschool Children and Their Families
The aim of the present study was to evaluate the perceived impact of dental caries and dental pain on oral health-related quality of life (OHRQoL) among preschool children and their families. A cross-sectional study was conduct with 843 preschool children in Campina Grande, Brazil. Parents/caregivers answered a questionnaire on socio-demographic information, their child's general/oral health and history of dental pain. The Brazilian version of the Early Childhood Oral Health Impact Scale was administered to determine the perceived impact of caries and dental pain on OHRQoL. Children have undergone an oral examination. Logistic regression for complex sample was used to determine associations between the dependent and independent variables (OR: odds ratio; α = 5%).
The present study received approval from the Human Research Ethics Committee of the State
University of Paraíba (Brazil) under process number 00460133000-11 in compliance with
Resolution 196/96 of the Brazilian National Health Council.
A school-based, cross-sectional study was carried out involving male and female children
aged three to five years enrolled at private and public preschools in the city of Campina
Grande, Brazil. Campina Grande is an industrialized city in northeastern Brazil with a
population of 386,000 inhabitants and is divided into six administrative districts. The city
has considerable cultural, social and economic disparities, with a mean monthly income per
capita equal to US$ 110 and a Human Development Index of 0.72 [11]. The participants were
selected from a total population of 12,705 children in this age group and corresponded to
6.41% of the entire population and therefore representative of preschool children in Campina
Grande.
A two-phase sampling method was used to ensure representativeness. A list of preschools was
obtained from the Municipal Secretary of Education of Campina Grande. To ensure the
representativeness a sample calculation was done. Through a stratified sampling procedure,
preschools were selected at draw from each district of Campina Grande. Then the number of
schoolchildren from each preschool was proportional to the number of schoolchildren enrolled
in each district. The sample was obtained from the proportion estimation calculation.
Preschools were randomly selected by draw from each district in the first phase and children
were randomly selected from each preschool in the second phase. Eighteen of the 127 public
preschools and 15 of the 122 private preschools were randomly selected by lots. The sample
size was calculated with a 4% margin of error, a 95% confidence level and a 50% prevalence
rate of perceived impact on child and family OHRQoL. A correction factor of 1.2 was applied
to compensate for the design effect [12].
The minimum sample size was estimated at 720 schoolchildren, to which an additional 20% was
added to compensate for possible losses, giving a total sample of 864 schoolchildren.
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Observational Model: Case-Only, Time Perspective: Cross-Sectional
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