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GENOA ORAL GROWTH LONGITUDINAL STUDY (GeOrGS) (GeOrGS)

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ClinicalTrials.gov Identifier: NCT02798809
Recruitment Status : Unknown
Verified June 2016 by ALESSANDRO UGOLINI, University of Genova.
Recruitment status was:  Recruiting
First Posted : June 14, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
ALESSANDRO UGOLINI, University of Genova

Brief Summary:
The aim of the study is to follow a group of preschool children from early permanent dentition to determine the prevalence and incidence of caries malocclusions and to investigated the related risk factors as age, gender, ethnic origin and non-nutritive sucking habits, breathing disturbances, allergies, Dietary habits, oral hygiene status and dental care.

Condition or disease Intervention/treatment
Malocclusion Dental Caries Other: Clinical dental examination

Detailed Description:
Once a year a clinical examination were performed. Data were collected with a questionnaire, that was filled out by the parents before the clinical examination, which included questions on child's clinical history, the type of feeding, the use of baby-bottle, the history of non-nutritive sucking habits (dummy-sucking and digit sucking) and the consent to the clinical examination. Two World Health Organization (WHO) calibrated examiners carried out the clinical examinations. They were blinded to the information collected from the parental questionnaires. Dental examinations were performed in a classroom environment under natural light, using gloves and masks in compliance with the infection control protocol, mouth mirrors and disposable paper rulers to measure overjet and overbite (in millimeters). The occlusion was assessed in centric occlusion and was classified according to Foster and Hamilton criteria [Foster and Hamilton, 1969] Radiographic examination was not performed.

Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GENOA ORAL GROWTH STUDY: Longitudinal Investigation of Preschool and Primary School Children
Study Start Date : April 2012
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Group/Cohort Intervention/treatment
GeOrGS cohort
Clinical dental examination of all Children born in 2008 and 2009 in Chivari District (Italy)
Other: Clinical dental examination
Clinical dental examination and a questionnaire that was filled out by the parents before each clinical examination.




Primary Outcome Measures :
  1. Incidence (rate %) of Malocclusions and Caries [ Time Frame: longitudinal 3 years ]


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Ages Eligible for Study:   3 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children born in 2008 and 2009 in Chiavari District (Italy)
Criteria

Inclusion Criteria:

  • children born in 2008 and 2009 in Chiavari District (Italy)

Exclusion Criteria:

  • parents' lack of consent
  • absence at the date of the visit; no compliance
  • orthodontic treatment; marked occlusal wear or early
  • loss of primary teeth
  • alterations in the number, size and shape of teeth
  • syndromes or systemic problems affecting craniofacial growth
  • cleft palate.

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): NCT02798809


Contacts
Contact: Alessandro Ugolini, DDS, PhD +390103537309 alexugolini@yahoo.it

Locations
Italy
Ortohdontic Department - Univesity of Genoa Recruiting
Genova, Italy, 16100
Contact: Alessandro Ugolini, DDS MS Phd       alexugolini@yahoo.it   
Principal Investigator: Alessandro Ugolini, Phd         
Sponsors and Collaborators
University of Genova
Investigators
Principal Investigator: Alessandro Ugolini, DDS, PhD University of Genova

Responsible Party: ALESSANDRO UGOLINI, Researcher, University of Genova
ClinicalTrials.gov Identifier: NCT02798809     History of Changes
Other Study ID Numbers: UGenova
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Dental Caries
Malocclusion
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases