Analysis of Oral Health of Students and Former Students o... | NCT06853639

Studies
Analysis of Oral Health of Students and Former Students of Undergraduate and Postgraduate Programs at the University of São Paulo.

NCT06853639

Sponsor

University of Sao Paulo

Status

Recruiting

Last Update Posted

Mar 6, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Oral Health

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Feb 2029Estimated

Completion Date

Feb 2034Estimated

First Submitted Date

Feb 17, 2025

First Submission Date that Met QC Criteria

Feb 26, 2025

First Posted Date

Mar 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2025

Last Update Posted Date

Mar 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Alexandre Romito, Head of Periodontics Division, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate oral and systemic health conditions among students and former students of undergraduate and postgraduate programs at the University of São Paulo over five years. The primary focus is to understand how oral health impacts academic performance and attendance, providing insights for health promotion strategies within the university community.

Detailed Description

The study employs a prospective cohort design to explore multiple health-related outcomes, including periodontal health, oral health literacy, and the prevalence of caries. The data collected will also examine social and behavioral predictors of oral health, such as dietary habits, stress, and use of substances like tobacco and electronic cigarettes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dental students		Dental students: people who are aware of oral health problems and adhere to ideal means of prevention.
Non-Dental students		Non-dental students: people who have little awareness of oral health problems and have unknown adherence to ideal means of prevention.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plaque index	Primary outcome: plaque index	through study completion, an average of 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Current and former undergraduate and postgraduate students of the University of São Paulo.

Exclusion Criteria:

1. Individuals who do not consent to participate.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Undergraduate and graduate students at the University of São Paulo

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giuseppe A Romito, Head of Periodontics division	Contact	+5511992051939		garomito@usp.br
Claudio M Pannuti	Contact	+551130917833		pannuti@usp.br

Overall Officials

Name	Affiliation	Role
Giuseppe A Romito	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculdade de Odontologia da USP	Recruiting	São Paulo		05508-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided