Visual Oral Examination in Primary Health Care for Early Detection of Oral Cancer: Targeting High-Risk Individuals in the Municipality of Rio de Janeiro
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,152
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Oral cancer (OC) is a significant public health concern in Brazil, with the country having the highest incidence of the disease in Latin America. It ranks as the fourth most common cancer among men in the southeast region. This condition carries substantial morbidity and mortality, largely due to the majority of patients being diagnosed at advanced stages, leading to elevated treatment costs, prolonged rehabilitation, and profound social impacts such as loss of labor capacity and exclusion from social environments.
Squamous cell carcinoma, constituting 90 to 95% of OC cases, primarily affects men over 50 years old, with an emerging incidence in individuals under 40. In Brazil, the lateral border of the tongue is the primary site, characterized by invasive growth, significant recurrence rates, and metastasis to regional lymph nodes.
The main etiological factors for OC include tobacco and alcohol for intraoral lesions, prolonged exposure to ultraviolet (UV) radiation for lip cancer, and, for oropharyngeal cancer, human papillomavirus (HPV) infection. Cultural characteristics, socioeconomic level, and access to public health services also contribute to the variation in oral cancer incidence.
Primary prevention is paramount and involves educating individuals on behavioral risk factors, limiting tobacco and alcohol use, sun protection for the lips, HPV vaccination for oropharyngeal cancer prevention, and maintaining a healthy diet. Secondary prevention focuses on early disease through detection for pre-clinical signs and early diagnosis for individuals exhibiting suspected symptoms.
The justification for implementing a population screening program as a public health policy is based on established criteria. While OC meets ten out of the 19 criteria presented at the Global Oral Cancer Forum in 2016, its cost-effectiveness remains unproven, unlike breast and cervical cancer, which have well-defined population screening protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Individuals who have had a regular dental visit within the last 12 months
结局指标
主要结局
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
时间窗: one year
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.
次要结局
未报告次要终点
研究者
Marcia Frias Pinto Marinho
Principal Investigator, Ph.D. Candidate in Dentistry, Department of Oral Diagnosis and Pathology, School of Dentistry
Universidade Federal do Rio de Janeiro