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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06381414
Other study ID # ChildhoodEarlyOralAging
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date December 20, 2024

Study information

Verified date April 2024
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Early Oral Aging Syndrome (EOAS) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. In this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the Early Childhood Oral Aging Syndrome (EOAS) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. Participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the University Nove de Julho, will be selected. Children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. A questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. Subsequently, a clinical examination will be conducted using the new Early Childhood Oral Aging Syndrome (EOAS) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores I to III that should be used concomitantly in cases of enamel defects presence, in addition to measuring the Vertical Dimension of Occlusion (VDO). EOAS scores will be computed and statistically analyzed for deciduous dentition with a significance level of P<0.05.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 183
Est. completion date December 20, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria: - Children from three to six years of age with complete deciduous teeth; - Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic Exclusion Criteria: - Children with amelogenesis or dentinogenesis imperfecta - Children undergoing orthodontic treatment - Children with a genetic syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Observation
Identify the prevalence of early wear in primary dentition, using Childhood Early Oral Aging Syndrome (CEOAS) index. The CEOAS index involves scores of 0 to 3 for the assessment of tooth wear and dental management, whereas scores of I, II and III are used concomitantly in cases of the presence of enamel defects.

Locations

Country Name City State
Brazil Nove de Julho University São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Tooth Wear and Dental Management CEOAS 0 - Absence of signs
CEOAS 1 - Mild: Presence of clinical signs in reversible stages, without sensitivity. Such cases require follow-up.
CEOAS 2 - Moderate: Presence of advanced signs with sensitivity and compromised function. Such cases require restorative treatment and management of the sensitivity.
CEOAS 3 - Severe: Presence of severe signs with pulp involvement and the risk of the loss of the tooth. Such cases require more invasive and rehabilitative treatment.
Baseline
Primary Presence of Enamel Defects CEOAS I- Presence of PMH - Demarcated opacities
CEOAS II - Presence of PMH - Post-eruption fractures
CEOAS III - Presence of fluorosis
Baseline
Primary Vertical Dimension of Occlusion The VDO measurement will be carried out with the participant sitting, head aligned with the body and gaze fixed on a specific point. Measurements will be taken in centric occlusion and will be done with the aid of a digital caliper: The following distances will be measured with the aid of a digital caliper: 1° Distance from the corner of the lip to the corner of the eye; 2° Distance from the base of the nose to the chin. Baseline
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