Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02443207
Other study ID # CNPq 471-790.2011/7
Secondary ID
Status Completed
Phase N/A
First received May 6, 2015
Last updated May 12, 2015
Start date January 2013
Est. completion date May 2014

Study information

Verified date May 2015
Source Universidade Estadual da Paraiba
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational [Patient Registry]

Clinical Trial 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%).


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.


Recruitment information / eligibility

Status Completed
Enrollment 843
Est. completion date May 2014
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 5 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ana Flavia Granville-Garcia

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dental Pain Self-reported dental pain informed in a questionnaire nine months No
Primary Quality of life Self-reported dental pain informed in a questionnaire (OHRQoL) nine months No
See also
  Status Clinical Trial Phase
Completed NCT04127929 - Investigation of Glass Carbomer Performance N/A
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Active, not recruiting NCT04475679 - Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy N/A
Completed NCT05438381 - Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars N/A
Not yet recruiting NCT03037814 - Clinical Performance of Restorative Materials in Primary Teeth N/A
Active, not recruiting NCT05202665 - Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion N/A
Terminated NCT01147835 - Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers N/A
Not yet recruiting NCT04033263 - Maintaining Oral Health With Bio-products N/A
Enrolling by invitation NCT04438252 - Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions N/A
Not yet recruiting NCT03609034 - Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02473107 - Impact of Detecting Initial and Active Caries Lesions in Primary Teeth N/A
Active, not recruiting NCT02537184 - Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children N/A
Completed NCT01950546 - Nanosilver Fluoride to Prevent Dental Biofilms Growth Phase 1
Recruiting NCT02734420 - Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial Phase 1
Completed NCT02020681 - Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions N/A
Completed NCT02426619 - Arresting Active Dental Caries in Preschool Children by Topical Fluorides Phase 2/Phase 3
Completed NCT02234609 - Effectiveness of Modified Class IV Atraumatic Restorative Treatment N/A
Completed NCT01623362 - Evaluation of a Low Fluoride Dentifrice for Caries Control Phase 3