- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236700
Buccal Evaluation of Mobile Beach Workers
Oral and Buccal Evaluation of Mobile Beach Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- be walking beach worker
Exclusion Criteria:
- not wanting to participate in the evaluation
Study Plan
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
Investigators
- Principal Investigator: CAIO VINICIUS G ROMAN TORRES, University of Santo Amaro
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SantosMU7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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