NCT06381414

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

April 17, 2024

Last Update Submit

November 14, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Interventions

ObservationBEHAVIORAL

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.

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic

You may qualify if:

  • Children from three to six years of age with complete deciduous teeth;
  • Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic

You may not qualify if:

  • Children with amelogenesis or dentinogenesis imperfecta
  • Children undergoing orthodontic treatment
  • Children with a genetic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 03155-000, Brazil

RECRUITING

Related Publications (1)

  • Spinola SG, Sobral APT, Mandetta ARH, Gimenez T, Goncalves MLL, Soares PV, Santos EM, Imparato JCP, Horliana ACRT, Mesquita-Ferrari RA, Motta LJ, Fernandes KPS, Bussadori SK. Childhood early oral ageing syndrome: prevalence and association with possible aetiological factors and consequences for the vertical dimension of occlusion: protocol for a cross-sectional study. BMJ Open. 2024 Dec 23;14(12):e090085. doi: 10.1136/bmjopen-2024-090085.

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 24, 2024

Study Start

May 1, 2024

Primary Completion

January 31, 2025

Study Completion

June 20, 2025

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations