GENOA ORAL GROWTH LONGITUDINAL STUDY (GeOrGS) (GeOrGS)

June 6, 2019 updated by: ALESSANDRO UGOLINI, University of Genova

GENOA ORAL GROWTH STUDY: Longitudinal Investigation of Preschool and Primary School Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16100
        • Recruiting
        • Ortohdontic Department - Univesity of Genoa
        • Contact:
        • Principal Investigator:
          • Alessandro Ugolini, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children born in 2008 and 2009 in Chiavari District (Italy)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence (rate %) of Malocclusions and Caries
Time Frame: longitudinal 3 years
longitudinal 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Genova

Investigators

  • Principal Investigator: Alessandro Ugolini, DDS, PhD, University of Genova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGenova

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on Clinical dental examination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe