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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06378385
Other study ID # DevelopmentCEOAS
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

Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 6
Est. completion date December 20, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: -Dental surgeons Exclusion Criteria: -Other healthcare professionals

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Childhood Early Oral Aging Syndrome index
Development and validation of a Childhood Early Oral Aging Syndrome index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in the pediatric population.

Locations

Country Name City State
Brazil Universidade Metropolitana de Santos - UNIMES Santos São Paulo

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 Development of CEOAS index The Childhood Early Oral Aging Syndrome index will be to investigate clinical signs and symptoms related to the early loss of dental structure associated with the most prevalent enamel defects, which significantly contribute to oral aging. The clinical management of tooth wear is also addressed in CEOAS scores 1, 2 and 3. Current indices used for non-carious conditions do not enable the concomitant investigation of enamel defects, which makes the proposed index innovative and of extreme important to epidemiological surveys. Understanding the prevalence of factors that either separately or synergically accelerate the process of early aging is useful to the establishment of novel treatment strategies.
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, as show in Table 1
Immediately
Secondary Validation of CEOAS index Content validation will not be performed in person. The online content validation form will be sent to the specialists with the items and criteria to be assessed (Table 1) 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.
CEOAS I Presence of PSMH - Demarcated opacities CEOAS II Presence of PSMH - Post-eruption fractures CEOAS III Presence of fluorosis
Immediately
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