Clinical trial NCT02443207: Impact of Dental Pain on the Quality of Life
Official title: Perceived Impact of Dental Pain on the Quality of Life of Preschool Children and Their Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Pain
Dental Caries
Keywords: Toothache
Quality of life
Oral Health
Children
Lead sponsor: Universidade Estadual da Paraiba
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 843
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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%).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dental Pain
timeFrame: nine months
measure: Quality of life
timeFrame: nine months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UEPB
name: Ana Flavia Granville-Garcia, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pahel BT, Rozier RG, Slade GD. Parental perceptions of children's oral health: the Early Childhood Oral Health Impact Scale (ECOHIS). Health Qual Life Outcomes. 2007 Jan 30;5:6. doi: 10.1186/1477-7525-5-6.
citation: Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
citation: Clementino MA, Pinto-Sarmento TC, Costa EM, Martins CC, Granville-Garcia AF, Paiva SM. Association between oral conditions and functional limitations in childhood. J Oral Rehabil. 2015 Jun;42(6):420-9. doi: 10.1111/joor.12273. Epub 2015 Jan 19.