AgingNCT06378385
Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition
An observational study of Aging, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aging
- What is being tested?
- Childhood Early Oral Aging Syndrome index
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2024to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dental surgeons with experience in the subject of Childhood Early Oral Aging Syndrome
Who may be able to join
- -Dental surgeons
Who cannot join
- -Other healthcare professionals
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Metropolitana de Santos - UNIMES
Santos, São Paulo, 11045-002
About this study
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.
- Conditions
- Aging
- Being tested
- Childhood Early Oral Aging Syndrome index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childhood Early Oral Aging Syndrome indexBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Childhood Early Oral Aging Syndrome index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately
Secondary outcomes (1)
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
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378385
- Sponsor's protocol ID
- DevelopmentCEOAS
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
Publications
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.
PubMed 39453950
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition
- ClinicalTrials.gov ID
- NCT06378385
- Acronym / sponsor ID
- DevelopmentCEOAS
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Behavioral: Childhood Early Oral Aging Syndrome indexDevelopment 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dental surgeons with experience in the subject of Childhood Early Oral Aging Syndrome
Key inclusion criteria (1 listed)
- -Dental surgeons
Key exclusion criteria (1 listed)
- -Other healthcare professionals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Childhood Early Oral Aging Syndrome indexDevelopment 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. | Behavioural | Observational |
Primary outcome
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
1 secondary outcome
Validation of CEOAS index
Time frame: Immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 39453950Honorio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of CEOAS index (time frame: Immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06378385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.