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Buccal Evaluation of Mobile Beach Workers

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236700
Recruitment Status : Active, not recruiting
First Posted : January 22, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos

Brief Summary:
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.

Condition or disease Intervention/treatment
Buccal Cavity Cancer Labial Lipoma Other: Oral clinical exam

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Oral and Buccal Evaluation of Mobile Beach Workers
Actual Study Start Date : November 22, 2019
Actual Primary Completion Date : December 1, 2019
Estimated Study Completion Date : February 27, 2020

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

Other: Oral clinical exam
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  • be walking beach worker

Exclusion Criteria:

  • not wanting to participate in the evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236700


Locations
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Brazil
Caio Vinicius Gonçalves Roman Torres
Santos, SP, Brazil, 11015001
Sponsors and Collaborators
Universidade Metropolitana de Santos
Investigators
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Principal Investigator: CAIO VINICIUS G ROMAN TORRES University of Santo Amaro

Publications of Results:
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Responsible Party: CAIO VINICIUS G. ROMAN TORRES, Professor, Universidade Metropolitana de Santos
ClinicalTrials.gov Identifier: NCT04236700    
Other Study ID Numbers: SantosMU7
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CAIO VINICIUS G. ROMAN TORRES, Universidade Metropolitana de Santos:
Buccal cancer
Additional relevant MeSH terms:
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Lipoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms