AgingNCT06381414
Childhood Early Oral Aging Syndrome: Prevalence, Etiological Factors, and Consequences on Occlusion
An observational study of Aging, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Aging
- What is being tested?
- Observation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 183 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2024to 20 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic
Who may be able to join
- Children from three to six years of age with complete deciduous teeth;
- Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic
Who cannot join
- Children with amelogenesis or dentinogenesis imperfecta
- Children undergoing orthodontic treatment
- Children with a genetic syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Nove de Julho University
São Paulo, São Paulo, 03155-000
Sandra K Bussadori, PhD, +55 11 2633-9000, sandra.skb@gmail.com
About this study
Official title: Childhood Early Oral Aging Syndrome: Prevalence, Associated Etiological Factors, and Consequences on Vertical Dimension of Occlusion (VDO): A Cross-Sectional Study
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.
- Conditions
- Aging
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 May 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion20 Jun 2025 (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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 183 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
- NCT06381414
- Sponsor's protocol ID
- ChildhoodEarlyOralAging
- Status last verified
- Nov 2024
- First submitted
- 17 Apr 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39719276
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Early Oral Aging Syndrome: Prevalence, Associated Etiological Factors, and Consequences on Vertical Dimension of Occlusion (VDO): A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06381414
- Acronym / sponsor ID
- ChildhoodEarlyOralAging
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 24 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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic
Key inclusion criteria (2 listed)
- Children from three to six years of age with complete deciduous teeth;
- Children regularly enrolled for dental care at the Uninove pediatric dentistry clinic
Key exclusion criteria (3 listed)
- Children with amelogenesis or dentinogenesis imperfecta
- Children undergoing orthodontic treatment
- Children with a genetic syndrome
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 |
|---|---|---|
| ObservationIdentify 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. | Behavioural | – |
Primary outcome
Assessment of Tooth Wear and Dental Management
Time frame: Baseline
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.
Presence of Enamel Defects
Time frame: Baseline
CEOAS I- Presence of PMH - Demarcated opacities CEOAS II - Presence of PMH - Post-eruption fractures CEOAS III - Presence of fluorosis
Vertical Dimension of Occlusion
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 39719276Spinola 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.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Tooth Wear and Dental Management (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT06381414, 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 18 Nov 2024.