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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
Sponsor:
Information provided by (Responsible Party):
Ana Flavia Granville-Garcia, Universidade Estadual da Paraiba

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%).

Condition or disease
Dental Pain Dental Caries

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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 843 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Ana Flavia Granville-Garcia
Investigators
Principal Investigator: Ana Flavia Granville-Garcia, Professor UEPB

Publications of Results:
Other Publications:
Responsible Party: Ana Flavia Granville-Garcia, DDS, PhD, Professor, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier: NCT02443207     History of Changes
Other Study ID Numbers: CNPq 471-790.2011/7
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Ana Flavia Granville-Garcia, Universidade Estadual da Paraiba:
Toothache
Quality of life
Oral Health
Children

Additional relevant MeSH terms:
Dental Caries
Toothache
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms