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Completed

NCT Number: NCT02443207

Impact of Dental Pain on the Quality of Life

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%).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The inclusion criteria were age three to five years of age, enrollment in preschool or daycare and free of any systemic disease according to parents'/caregivers' reports.
  • Parental authorization was required and was obtained through a signed statement of informed consent.

Exclusion criteria

  • Children that did not accept clinical examination or have mental illness were excluded from the study

Treatment and study plan

Primary outcomes

  1. Dental Pain

    Time frame: nine months

    Self-reported dental pain informed in a questionnaire

  2. Quality of life

    Time frame: nine months

    Self-reported dental pain informed in a questionnaire (OHRQoL)

Sponsors and collaborators

Lead sponsor

Ana Flavia Granville-Garcia

Other

Registry information

Official study title

Perceived Impact of Dental Pain on the Quality of Life of Preschool Children and Their Families

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 13, 2015
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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