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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02798809
Other study ID # UGenova
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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