Impact of Dental Pain on the Quality of Life
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|ClinicalTrials.gov Identifier: NCT02443207|
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
|Condition or disease|
|Dental Pain Dental Caries|
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 . 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 .
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||843 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Perceived Impact of Dental Pain on the Quality of Life of Preschool Children and Their Families|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||May 2014|
- Dental Pain [ Time Frame: nine months ]Self-reported dental pain informed in a questionnaire
- Quality of life [ Time Frame: nine months ]Self-reported dental pain informed in a questionnaire (OHRQoL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443207
|Principal Investigator:||Ana Flavia Granville-Garcia, Professor||UEPB|