NCT06378385

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

April 18, 2024

Last Update Submit

April 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Validation of CEOAS index

    Immediately

Study Arms (1)

Observational

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.

Behavioral: Childhood Early Oral Aging Syndrome index

Interventions

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.

Observational

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Dental surgeons with experience in the subject of Childhood Early Oral Aging Syndrome

You may qualify if:

  • Dental surgeons

You may not qualify if:

  • Other healthcare professionals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Metropolitana de Santos - UNIMES

Santos, São Paulo, 11045-002, Brazil

Location

Related Publications (1)

  • Honorio Mandetta AR, Gimenez T, Sobral APT, Spinola SG, Goncalves MLL, Soares PV, Santos EM, Imparato JCP, Horliana ACRT, Mesquita-Ferrari RA, Motta LJ, Fernandes KPS, Kalil Bussadori S. Development and content validation of the Childhood Early Oral Aging Syndrome (CEOAS) index for the deciduous dentition: Research protocol. PLoS One. 2024 Oct 25;19(10):e0310543. doi: 10.1371/journal.pone.0310543. eCollection 2024.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 22, 2024

Study Start

May 1, 2024

Primary Completion

October 31, 2024

Study Completion

December 20, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations