Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04081038 |
| Other study ID # |
Oral cancer screening |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 31, 2019 |
| Est. completion date |
June 15, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Dalarna County Council, Sweden |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
