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Mouth NeoplasmsNCT06231537

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

A study testing Visual oral examination in people with Mouth Neoplasms, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 120 yearsHealthy volunteers can take part
Conditions the study is for
Mouth Neoplasms
What is being tested?
Visual oral examination
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,152 participants
Where
1 siteBrazil
Study dates
1 Dec 2023to 10 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Health Units of the Municipality of Rio de Janeiro

    Rio de Janeiro, Rio de Janeiro, 23070-220

Other trials in Brazil

About this study

Official title: Visual Oral Examination in Primary Health Care for Early Detection of Oral Cancer: Targeting High-Risk Individuals in the Municipality of Rio de Janeiro

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.

Read the detailed description

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.

Although a clinical trial in Kerala, India, did not demonstrate reduced OC mortality through population monitoring, a reanalysis in 2021 highlighted the effectiveness of targeted preventive mouth examinations by trained health professionals for at-risk populations.

In many countries, including Brazil, opportunistic examinations of the mouth's soft tissues are recommended for early diagnosis of lesions, but the majority of oral cancer cases are still diagnosed at advanced stages. The National Oral Health Policy, established in 2004, aims to promote, prevent, recover, and maintain oral health through primary care and specialized dental centers.

Recognizing structural and social determinants is crucial for effective prevention, detection, and management of OC. The "inverse screening law" highlights challenges in opportunistic examinations, and barriers to accessibility and diagnostic delays persist, especially among the elderly.

Despite the current strategy in Brazil relying on opportunistic testing, the majority of OC cases are diagnosed late. Weaknesses in the city of Rio de Janeiro, including low population coverage in Oral Health in Primary Care and limited access for at-risk populations, underscore the likely ineffectiveness of the current preventive strategy.

The present study is justified by the imperative to expand access to preventive oral examinations for individuals at increased risk for OC, aiming for early diagnosis and subsequently reducing mortality and morbidity.

Conditions
Mouth Neoplasms
Being tested
Visual oral examination
Keywords
Mouth Neoplasms, early diagnosis, public health, prevention
Medical subject headings
Mouth Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual oral examinationDiagnostic 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.

Study groups in NCT06231537
Study groupRoleWhat they receive
Control GroupNo interventionHealth 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 GroupExperimentalHealth 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.
Receives: Diagnostic Test: Visual oral examination
Campaign GroupExperimentalHealth 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.
Receives: Diagnostic Test: Visual oral examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2023
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
cluster randomized clinical trial
Masking
None (open label)
Enrolment
1,152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231537
Sponsor's protocol ID
O/OC 2023-2024
Status last verified
May 2026
First submitted
12 Jan 2024
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rutkowska 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.

    PubMed 32598579

  • Gormley 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.

    PubMed 35852216

  • Walsh 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.

    PubMed 34891214

  • Hertrampf 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.

    PubMed 35249159

  • Zamani 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.

    PubMed 32460181

  • Nielsen 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.

    PubMed 34372545

  • Abati 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.

    PubMed 33302498

  • Nagao T, Warnakulasuriya S. Screening for oral cancer: Future prospects, research and policy development for Asia. Oral Oncol. 2020 Jun;105:104632. doi: 10.1016/j.oraloncology.2020.104632. Epub 2020 Apr 18.

    PubMed 32315954

  • Thankappan K, Subramanian S, Balasubramanian D, Kuriakose MA, Sankaranarayanan R, Iyer S. Cost-effectiveness of oral cancer screening approaches by visual examination: Systematic review. Head Neck. 2021 Nov;43(11):3646-3661. doi: 10.1002/hed.26816. Epub 2021 Jul 14.

    PubMed 34260118

  • Cheung LC, Ramadas K, Muwonge R, Katki HA, Thomas G, Graubard BI, Basu P, Sankaranarayanan R, Somanathan T, Chaturvedi AK. Risk-Based Selection of Individuals for Oral Cancer Screening. J Clin Oncol. 2021 Feb 20;39(6):663-674. doi: 10.1200/JCO.20.02855. Epub 2021 Jan 15.

    PubMed 33449824

  • Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Thomas G, Anju G, Mathew B. Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol. 2013 Apr;49(4):314-21. doi: 10.1016/j.oraloncology.2012.11.004. Epub 2012 Dec 21.

    PubMed 23265945

  • Bouvard V, Nethan ST, Singh D, Warnakulasuriya S, Mehrotra R, Chaturvedi AK, Chen TH, Ayo-Yusuf OA, Gupta PC, Kerr AR, Tilakaratne WM, Anantharaman D, Conway DI, Gillenwater A, Johnson NW, Kowalski LP, Leon ME, Mandrik O, Nagao T, Prasad VM, Ramadas K, Roitberg F, Saintigny P, Sankaranarayanan R, Santos-Silva AR, Sinha DN, Vatanasapt P, Zain RB, Lauby-Secretan B. IARC Perspective on Oral Cancer Prevention. N Engl J Med. 2022 Nov 24;387(21):1999-2005. doi: 10.1056/NEJMsr2210097. Epub 2022 Oct 18. No abstract available.

    PubMed 36378601

  • Bouvard V, Wentzensen N, Mackie A, Berkhof J, Brotherton J, Giorgi-Rossi P, Kupets R, Smith R, Arrossi S, Bendahhou K, Canfell K, Chirenje ZM, Chung MH, Del Pino M, de Sanjose S, Elfstrom M, Franco EL, Hamashima C, Hamers FF, Herrington CS, Murillo R, Sangrajrang S, Sankaranarayanan R, Saraiya M, Schiffman M, Zhao F, Arbyn M, Prendiville W, Indave Ruiz BI, Mosquera-Metcalfe I, Lauby-Secretan B. The IARC Perspective on Cervical Cancer Screening. N Engl J Med. 2021 Nov 11;385(20):1908-1918. doi: 10.1056/NEJMsr2030640. No abstract available.

    PubMed 34758259

  • Ribeiro MFA, Oliveira MCM, Leite AC, Bruzinga FFB, Mendes PA, Grossmann SMC, de Araujo VE, Souto GR. Assessment of screening programs as a strategy for early detection of oral cancer: a systematic review. Oral Oncol. 2022 Jul;130:105936. doi: 10.1016/j.oraloncology.2022.105936. Epub 2022 Jun 2.

    PubMed 35662028

  • D'souza S, Addepalli V. Preventive measures in oral cancer: An overview. Biomed Pharmacother. 2018 Nov;107:72-80. doi: 10.1016/j.biopha.2018.07.114. Epub 2018 Aug 3.

    PubMed 30081204

Questions about this trial

What is this clinical trial studying?

A study testing Visual oral examination in people with Mouth Neoplasms, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231537, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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