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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04236700
Other study ID # SantosMU7
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 22, 2019
Est. completion date December 27, 2025

Study information

Verified date March 2024
Source Universidade Metropolitana de Santos
Contact CAIO VINICIUS G ROMAN TORRES
Phone 13991304774
Email CVGRT@HOTMAIL.COM
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 27, 2025
Est. primary completion date March 27, 2022
Accepts healthy volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - be walking beach worker Exclusion Criteria: - not wanting to participate in the evaluation

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Brazil Caio Torres Santos SP
Brazil Caio Vinicius Gonçalves Roman Torres Santos SP

Sponsors (1)

Lead Sponsor Collaborator
Universidade Metropolitana de Santos

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Campisi G, Margiotta V. Oral mucosal lesions and risk habits among men in an Italian study population. J Oral Pathol Med. 2001 Jan;30(1):22-8. doi: 10.1034/j.1600-0714.2001.300104.x. Erratum In: J Oral Pathol Med 2002 Sep;31(8):504. — View Citation

English DR, Armstrong BK, Kricker A, Fleming C. Sunlight and cancer. Cancer Causes Control. 1997 May;8(3):271-83. doi: 10.1023/a:1018440801577. — View Citation

Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary number of workers with labial injuries beach workers who do not adopt protective measures may have tissue damage to their lips 2 months