Clinical trial · Interventional
Visual Oral Examination for Early Detection of Oral Cancer in High-Risk Individuals
Visual Oral Examination in Primary Health Care for Early Detection of Oral Cancer: Targeting High-Risk Individuals in the Municipality of Rio de Janeiro
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Visual oral examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 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.
- type
- EXPERIMENTAL
- label
- Active Screening Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Individuals who have had a regular dental visit within the last 12 months
References
Publications (36)
- BACKGROUNDRutkowska M, Hnitecka S, Nahajowski M, Dominiak M, Gerber H. Oral cancer: The first symptoms and reasons for delaying correct diagnosis and appropriate treatment. Adv Clin Exp Med. 2020 Jun;29(6):735-743. doi: 10.17219/acem/116753. PMID 32598579
- BACKGROUNDGormley M, Gray E, Richards C, Gormley A, Richmond RC, Vincent EE, Dudding T, Ness AR, Thomas SJ. An update on oral cavity cancer: epidemiological trends, prevention strategies and novel approaches in diagnosis and prognosis. Community Dent Health. 2022 Aug 30;39(3):197-205. doi: 10.1922/CDH_00032Gormley09. PMID 35852216
- BACKGROUNDWalsh T, Warnakulasuriya S, Lingen MW, Kerr AR, Ogden GR, Glenny AM, Macey R. Clinical assessment for the detection of oral cavity cancer and potentially malignant disorders in apparently healthy adults. Cochrane Database Syst Rev. 2021 Dec 10;12(12):CD010173. doi: 10.1002/14651858.CD010173.pub3. PMID 34891214
- BACKGROUNDHertrampf K, Jurgensen M, Wahl S, Baumann E, Wenz HJ, Wiltfang J, Waldmann A. Early detection of oral cancer: a key role for dentists? J Cancer Res Clin Oncol. 2022 Jun;148(6):1375-1387. doi: 10.1007/s00432-022-03962-x. Epub 2022 Mar 6. PMID 35249159
- BACKGROUNDZamani M, Gronhoj C, Jensen DH, Carlander AF, Agander T, Kiss K, Olsen C, Baandrup L, Nielsen FC, Andersen E, Friborg J, von Buchwald C. The current epidemic of HPV-associated oropharyngeal cancer: An 18-year Danish population-based study with 2,169 patients. Eur J Cancer. 2020 Jul;134:52-59. doi: 10.1016/j.ejca.2020.04.027. Epub 2020 May 24. PMID 32460181
- BACKGROUNDNielsen KJ, Jakobsen KK, Jensen JS, Gronhoj C, Von Buchwald C. The Effect of Prophylactic HPV Vaccines on Oral and Oropharyngeal HPV Infection-A Systematic Review. Viruses. 2021 Jul 11;13(7):1339. doi: 10.3390/v13071339. PMID 34372545
- BACKGROUNDAbati S, Bramati C, Bondi S, Lissoni A, Trimarchi M. Oral Cancer and Precancer: A Narrative Review on the Relevance of Early Diagnosis. Int J Environ Res Public Health. 2020 Dec 8;17(24):9160. doi: 10.3390/ijerph17249160.