Buccal Evaluation of Mobile Beach Workers

March 14, 2024 updated by: CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos

Oral and Buccal Evaluation of Mobile Beach Workers

Tumors in the oral region occur more frequently in men over 40, but can affect people of both gender and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Tumors in the oral region occur more frequently in men over 40, but can affect people of both sexes and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature. Firstly, information about the care, symptoms and forms of prevention will be explained for each worker approached, if the individual agrees to an oral examination, it can be performed by evaluating lips and peri-oral mucosa and within the needs of oral treatment, it can be referred for treatment at the clinic of the Dentistry Especialist Center of Santos/SP The street vendors who underwent the first assessment will be visited 2 more times according to the schedule, after the carnival of 2020 being the last assessment and thus being able to have data on the effectiveness of the information and past care during the visits made. As expected results, a greater awareness of the dangers of sun exposure, greater protection care and the ability to carry out self-examination at home being an information disseminator.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: CAIO VINICIUS G ROMAN TORRES
  • Phone Number: 13991304774
  • Email: CVGRT@HOTMAIL.COM

Study Locations

    • SP
      • Santos, SP, Brazil, 11015001
        • Recruiting
        • Caio Vinicius Gonçalves Roman Torres
        • Contact:
          • CAIO VINICIUS GONÇALVES G ROMAN TORRES
          • Phone Number: +5513991304774
          • Email: CVGRT@HOTMAIL.COM
      • Santos, SP, Brazil, 11045
        • Active, not recruiting
        • Caio Torres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The sample will consist of adult individuals of both sexes exposed to the sun directly and indirectly. The independent variables analyzed were: sex, age, income (in reais), years of study, type of work, frequency of weekly sun exposure, time of daily sun exposure, cumulative time of sun exposure and photoprotection measures at the occupational level. Health data will be collected on habits (alcoholism and smoking) and skin type, according to the Fitzpatrick classification

Description

Inclusion Criteria:

  • be walking beach worker

Exclusion Criteria:

  • not wanting to participate in the evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
beach workers

Workers must undergo clinical examinations of the upper and lower lips, performed by previously calibrated researchers, through semi-technical inspection and palpation maneuvers, in order to identify injuries. Photo cameras can be used to improve the visibility of the lips using the image enhancement feature, to confirm the diagnosis. The clinical examination will include: dryness, atrophy, scaly lesions, lip swelling, erythema, ulcerations, cloudy demarcations between the vermilion of the lip and skin, demarcated folds along the lip, white spots or plaques, crusts, stained or pale areas.

They should be evaluated with the application of a previously validated questionnaire containing information related to personal data, information on occupation and health was completed according to the responses of the volunteers. The OHIP-14 quality of life questionnaire will be applied together

Detailed anamnesis, with information regarding the time of sun exposure, protection measures, medical history and application of questionnaires will be carried out. Dental dental and tissue examination should be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of workers with labial injuries
Time Frame: 2 months
beach workers who do not adopt protective measures may have tissue damage to their lips
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: CAIO VINICIUS G ROMAN TORRES, University of Santo Amaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Actual)

March 27, 2022

Study Completion (Estimated)

December 27, 2025

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SantosMU7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The collected data will be imported into the Stata 10.0 software platform. Descriptive analysis of all data related to dependent and independent variables, chi-square statistical tests and calculation of prevalence ratios and the respective confidence intervals. The multiple analysis will be performed using the robust Poisson regression by the hybrid method parameter to estimate the prevalence rates of lip lesions adjusted for sex, age, type of work, photo-protection measures, use of lip protector, use of cap / hat, skin type, any habit (smoking or drinking). The significance level of 5% will be adopted for all tests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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