Visual Oral Examination for Early Detection of Oral Cancer in High-Risk Individuals

NCT06231537 | Completed

• 1 other identifier: O/OC 2023-2024
• Study Type: interventional
• Target: 1,152
• Locations: 1 country
• Sites: 1

Brief Summary

Oral cancer (OC) is a public health problem in Brazil, with high morbidity and mortality, mainly associated with late diagnosis, which implies high-cost treatments and great social impact, with aesthetic and functional sequelae. Smokers and alcoholics are at increased risk for the disease, being early detection the most effective way to increase survival. In Brazil, cancer plan recommends early diagnosis of OC through opportunistic examination, which is carried out during regular visits to the dentist. However, this strategy has not yet been able to reverse the late diagnosis, which may be due to the low access to dental appointments by the most vulnerable groups. Studies point to the effectiveness of the preventive physical examination of the mouth for early detection when directed to the high-risk population. The aim of the present study is to compare different strategies aimed at expanding the access of the high-risk population to preventive physical examination of the mouth. A cluster-randomized trial (control group and experimental groups I and II) will be carried out in Primary Health Care units in Programmatic Area 5.2 of the city of Rio de Janeiro (eight neighborhoods in the West Zone). In the control group, there will be no change in current care. In both experimental groups, Community Agents and health professionals will be trained in OC prevention and instructed to call the users with high-risk for OC to the preventive examination of the mouth at the health unit. After 6 months, in experimental group I, an active search will be carried out for users who did not show up for the preventive examination, while in experimental group II, a campaign on OC will be carried out for a month, inviting the population to the preventive examination. After one year, the number of people at increased risk for OC examined in each group will be compared and correlated with sociodemographic and clinicopathological variables.

Conditions

Mouth Neoplasms

Keywords

Mouth Neoplasms; early diagnosis; public health; prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Preventive Oral Examinations among Individuals Aged 35 and Older, Smokers, and/or Alcohol Drinkers within One Year Post-Implementation of Strategies in Experimental Groups

  The descriptive characterization of the sample will be estimated for both the control and experimental groups, encompassing the absolute and relative counts of individuals aged 35 and older, smokers, and/or alcohol drinkers who underwent a preventive oral examination within one year following the implementation of strategies in the experimental groups.

  one year

Study Arms (3)

Control Group

NO INTERVENTION

Health professionals, including dentists (CD), dental hygienists (TSB), dental assistants (ASB), nurses, and general practitioners, will continue providing care to users in accordance with the existing Service Card protocols in the city of Rio de Janeiro. This ensures on-demand service for users seeking dental care. Additionally, they will continue to facilitate participation in the Tobacco Control Program for interested individuals, following the established protocol of the city of Rio de Janeiro. Notably, members of the control group will not partake in the qualification process conducted by this research project. However, in the event of positive results at the research's conclusion, consideration will be given to extending qualification opportunities to the control group as well.

Active Screening Group

EXPERIMENTAL

Health professionals (Community Health Agents, dentists, dental hygienists, dental assistants, nurses, and general practitioners) will undergo training focused on preventing OC, considering risk factors and highlighting the significance of preventive oral examinations for early diagnosis. Dentist and general practitioners will receive training to conduct oral examinations, enabling them to identify suspicious lesions and potentially malignant disorders. The qualification process will be conducted through face-to-face meetings and/or videoconferencing, supplemented by educational material delivered via the widely used messaging application (WhatsApp). Following qualification, tobacco users and excessive alcohol users will be invited to visit the Family Clinic for oral preventive examination. After six months, in the event that a user does not attend the Family Clinic, the Health Team will conduct an active search, through home visits or community outreach in bars.

Diagnostic Test: Visual oral examination

Campaign Group

EXPERIMENTAL

Health professionals (Community Health Agents, dentists, dental hygienists, dental assistants, nurses, and general practitioners) will be training focused on preventing OC, risk factors and highlighting the significance of preventive oral examinations for early diagnosis. Dentist and general practitioners will receive training to conduct oral examinations, enabling them to identify suspicious lesions and potentially malignant disorders. The qualification process will be conducted through face-to-face meetings or videoconferencing. Following qualification, tobacco and excessive alcohol users will be invited to visit the Family Clinic for oral examination. After six months, a public awareness campaign, over one month, will be conducted in the Family Clinics. This campaign will provide guidance on risk factors, signs and symptoms, and the importance of oral examinations.

Diagnostic Test: Visual oral examination

Interventions

Visual oral examination DIAGNOSTIC_TEST

Oral preventive examinations in the three groups will be conducted over a one-year period. Individuals with oral injuries will be referred to stomatology, aligning with the existing protocol. Histopathological examinations of the biopsied lesions will be performed at the Oral Pathology Laboratory of the Faculty of Dentistry at the Federal University of Rio de Janeiro, following the established procedures. Users diagnosed with malignancy will be directed to receive treatment at the reference hospital, with monitoring carried out by the Basic Health Unit responsible for coordinating care, in accordance with the current protocol. In addition to histopathological examinations, the Faculty of Dentistry will be available to conduct a physical examination and biopsy if the user is not attended to by the Municipal Health Department. This additional resource ensures comprehensive care for individuals who may not have immediate access to municipal health services.

Active Screening Group; Campaign Group

Eligibility Criteria

• Age: 35 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are regular smokers and/or chronic alcohol users
• Individuals registered as patients at Family Clinics within Programmatic Area 5.2 in the city of Rio de Janeiro
• Individuals aged 35 years or older

You may not qualify if:

• Individuals who have had a regular dental visit within the last 12 months

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Health Units of the Municipality of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 23070-220, Brazil

Location

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MeSH Terms

Conditions

Mouth Neoplasms; Disease

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcia F Marinho, MSc

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Ph.D. Candidate in Dentistry, Department of Oral Diagnosis and Pathology, School of Dentistry

Model Details: cluster randomized clinical trial

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 30, 2024
• Study Start: December 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 10, 2024
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)