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

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Brief Title

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

Official Title

Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies of Mucosal Lesions and Automated Artificial Intelligence Analysis of Cytology

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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Brush biopsy


Condition

Oral Cancer

Intervention

Brush biopsy


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

100

Start Date

August 31, 2019

Completion Date

June 30, 2021

Primary Completion Date

December 31, 2020

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Karin Gunnars Hellgren, +46 23 490155, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04081038

Organization ID

Oral cancer screening


Responsible Party

Principal Investigator

Study Sponsor

Dalarna County Council, Sweden


Study Sponsor

Karin Gunnars Hellgren, Study Chair, Public Dental Health Region Dalarna


Verification Date

May 2020