Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies

NCT ID: NCT04081038

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2023-06-15

Brief Summary

In 2007, The World Health Assembly (WHA) adopted a resolution to prevent oral cancer. The resolution urged the member states to ensure that measures against oral cancer was integrated into a national cancer control program by engaging and train dental personnel in screening, early diagnosis and treatment. Oral cancer is a severe oral health issue as it is potentially fatal and is the 5-6 most common tumor with approximately 275,000 cases for oral and 130,300 cases for pharyngeal cancers, excluding nasopharynx, globally. In Sweden,1000 new cases yearly is discovered and it is increasing. The explanation is an aging population and an increase in tonsil and tongue cancers caused by HPV, especially in younger subjects. This is due to changing sexual habits. Tumors caused by tobacco and alcohol are constant. Despite the decreasing prevalence of smoking and certain smoking-associated cancers, an increased incidence of tonsillar cancer has been seen in both Finland and Sweden. High risk HPV (hrHPV) oral cancer is also increasing.

Detailed Description

The 5 year survival of oral cancer in Sweden is 55 % and only 3-4% in advanced cases, with poor quality of life. The etiology is hrHPV, exposure to tobacco and alcohol in 65% and poor dental status. All are lifestyle factors so there are many opportunities for prevention and intervention. In 2016, 352 individuals in Sweden died in oral cancer compared with 135 individuals who died of cervical cancer. Leukoplakia (LP), erythroplakia (EP) and oral lichen planus (OLP) are the dominating oral premalignant entities. The diagnosis are clinical and often by biopsies. There are two types of leukoplakia, homogeneous and non-homogeneous. The nonhomogeneous have a risk of malignant transformation of 3.6-8.9% in Scandinavia. OLP is a chronic inflammatory lesion where the atrophic and erosive types have a risk of cancer development of 0.5-2%. The potential for prevention is high, as the risk factors are well known. The Clinical examination discloses any potentially malignant lesions. Screening for cervical cancer using brush sampling is a well-established method but for the early detection of oral premalignant and malignant lesions, this is not yet an accepted standard procedure. However, there are studies that clearly show that brush sampling is a reliable and safe method to identify oral cancer and their potentially malignant precursor. In subjects with suspected pre-malignant tissue changes, measures should be taken to organize to establish a diagnosis. The brush sampling technique are shown to be a faster less costly, and for the patient less troublesome technique than traditional incisional biopsies but both methods require today, referral to specialist care. Dental hygienists and dentists can most probably be trained to perform brush biopsies of oral premalignant lesions, and when diagnosed, the patient can be referred to a specialist to have the lesion excised, and required controls can possibly be carried out in the primary care. Dental health professionals have a responsibility to perform routine intra- and extraoral examination on their patients for detecting abnormalities. As dental hygienists and dentists often see their patients on a regular basis, they have the opportunity to provide this screening, and at an early stage detect abnormalities. In Sweden, education and training in examination of the oral mucosa is a part of the curriculum in dental hygienist education, so there is an expectation that the dental hygienist routinely perform tactile and visual examinations in practice. However, dental hygienists are not allowed to diagnose an oral mucosal lesion, but are trained to identify abnormalities and determine whether the patient needs referral to a dentist. It is also to expect that the dental hygienist and dentist are capable to identify risk behaviors, and recommend, and offer smoking cessation or refer the patient to a certified profession for smoking cessation. Being aware of the increasing number of head, neck, and oral tumors we need to focus on establishing easy, fast and affordable methods for diagnosis, managed at the general dental health clinics, preferably by dental hygienists and dentists.

Conditions

Oral Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Brush biopsy

Brush biopsy will be performed by dentists and dental hygienists

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years of age
• Understand Swedish

Exclusion Criteria

• Under 18 years of age
• Not understanding the Swedish language
• Previously mouth cancer diagnose

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dalarna County Council, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Kristina Edman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Gunnars Hellgren

Role: STUDY_CHAIR

Public Dental Health Region Dalarna

Locations

Kristina Edman

Falun, Dalarna County, Sweden

Public Dental Service

Falun, Dalarna County, Sweden

Countries

Sweden

Other Identifiers

Oral cancer screening

Identifier Type: -

Identifier Source: org_study_id