MalocclusionGeOrGSNCT02798809
GENOA ORAL GROWTH LONGITUDINAL STUDY (GeOrGS)
An observational study of Malocclusion and Dental Caries, run by University of Genova at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 3 to 3 years
- Conditions the study is for
- Malocclusion, Dental Caries
- What is being tested?
- Clinical dental examination
- How many people
- 270 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2012to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children born in 2008 and 2009 in Chiavari District (Italy)
Who may be able to join
- children born in 2008 and 2009 in Chiavari District (Italy)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ortohdontic Department - Univesity of Genoa
Genova, 16100
Alessandro Ugolini, DDS MS Phd, alexugolini@yahoo.it
Alessandro Ugolini, Phd
About this study
Official title: 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.
Read the 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.
- Conditions
- Malocclusion, Dental Caries
- Being tested
- Clinical dental examination
- Medical subject headings
- Malocclusion, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical dental examinationOther
Clinical dental examination and a questionnaire that was filled out by the parents before each clinical examination.
| Study group | Role | What they receive |
|---|---|---|
| GeOrGS cohort | Clinical dental examination of all Children born in 2008 and 2009 in Chivari District (Italy) Receives: Other: Clinical dental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (rate %) of Malocclusions and Caries
Measured: longitudinal 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start1 Apr 2012
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALESSANDRO UGOLINI, University of Genova
- Investigators
- Alessandro Ugolini, DDS, PhD, Principal investigator, University of Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798809
- Sponsor's protocol ID
- UGenova
- Acronym
- GeOrGS
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2016
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ugolini A, Porro F, Carli F, Agostino P, Silvestrini-Biavati A, Riccomagno E. Probabilistic graphical modelling of early childhood caries development. PLoS One. 2023 Oct 30;18(10):e0293221. doi: 10.1371/journal.pone.0293221. eCollection 2023.
PubMed 37903153
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENOA ORAL GROWTH STUDY: Longitudinal Investigation of Preschool and Primary School Children
- ClinicalTrials.gov ID
- NCT02798809
- Acronym / sponsor ID
- GeOrGS / UGenova
- Conditions
- Malocclusion, Dental Caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Study start
- 1 Apr 2012
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GeOrGS cohort | – | Other: Clinical dental examinationClinical dental examination of all Children born in 2008 and 2009 in Chivari District (Italy) |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children born in 2008 and 2009 in Chiavari District (Italy)
Key inclusion criteria (1 listed)
- children born in 2008 and 2009 in Chiavari District (Italy)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical dental examinationClinical dental examination and a questionnaire that was filled out by the parents before each clinical examination. | Other | GeOrGS cohort |
Primary outcome
Incidence (rate %) of Malocclusions and Caries
Time frame: longitudinal 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Derived from this study: PubMed 37903153Ugolini A, Porro F, Carli F, Agostino P, Silvestrini-Biavati A, Riccomagno E. Probabilistic graphical modelling of early childhood caries development. PLoS One. 2023 Oct 30;18(10):e0293221. doi: 10.1371/journal.pone.0293221. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Ugolini, DDS, PhD principal investigator
University of Genova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion and Dental Caries, run by University of Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Ugolini, DDS, PhD (+390103537309, alexugolini@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (rate %) of Malocclusions and Caries (time frame: longitudinal 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02798809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019; AzTrials last refreshed its copy on 29 Oct 2026.