Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06378385 |
|
Recruitment Status :
Not yet recruiting
First Posted : April 22, 2024
Last Update Posted : April 25, 2024
|
Sponsor:
University of Nove de Julho
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | April 18, 2024 | ||
| First Posted Date | April 22, 2024 | ||
| Last Update Posted Date | April 25, 2024 | ||
| Estimated Study Start Date | May 1, 2024 | ||
| Estimated Primary Completion Date | October 31, 2024 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
Development of CEOAS index [ Time Frame: Immediately ] 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
|
||
| Original Primary Outcome Measures | Same as current | ||
| Change History | |||
| Current Secondary Outcome Measures |
Validation of CEOAS index [ Time Frame: Immediately ] 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
|
||
| Original Secondary Outcome Measures | Same as current | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition | ||
| Official Title | Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition | ||
| 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. | ||
| Detailed Description | Not Provided | ||
| Study Type | Observational | ||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Probability Sample | ||
| Study Population | Dental surgeons with experience in the subject of Childhood Early Oral Aging Syndrome | ||
| Condition | Aging | ||
| 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.
|
||
| Study Groups/Cohorts | 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.
Intervention: Behavioral: Childhood Early Oral Aging Syndrome index
|
||
| Publications * | Not Provided | ||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
| Recruitment Information | |||
| Recruitment Status | Not yet recruiting | ||
| Estimated Enrollment |
6 | ||
| Original Estimated Enrollment | Same as current | ||
| Estimated Study Completion Date | December 20, 2024 | ||
| Estimated Primary Completion Date | October 31, 2024 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria: -Dental surgeons Exclusion Criteria: -Other healthcare professionals |
||
| Sex/Gender |
|
||
| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | |||
| Listed Location Countries | Brazil | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT06378385 | ||
| Other Study ID Numbers | DevelopmentCEOAS | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Current Responsible Party | Sandra Kalil Bussadori, University of Nove de Julho | ||
| Original Responsible Party | Same as current | ||
| Current Study Sponsor | University of Nove de Julho | ||
| Original Study Sponsor | Same as current | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | University of Nove de Julho | ||
| Verification Date | April 2024 | ||