GENOA ORAL GROWTH LONGITUDINAL STUDY (GeOrGS)

Dental Caries Clinical Trial

— GeOrGS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02798809
• Other study ID #: UGenova
• Status: Recruiting
• Start date: April 1, 2012
• Est. completion date: January 1, 2020

Study information

• Verified date: June 2019
• Source: University of Genova
• Contact: Alessandro Ugolini, DDS, PhD
• Phone: +390103537309
• Email: alexugolini[@]yahoo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Malocclusion

Intervention

Other:
• Clinical dental examination
Clinical dental examination and a questionnaire that was filled out by the parents before each clinical examination.

Locations

Country	Name	City	State
Italy	Ortohdontic Department - Univesity of Genoa	Genova

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence (rate %) of Malocclusions and Caries		longitudinal 3 years