Oral CancermouthcancerNCT04081038
Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies
An observational study of Oral Cancer, run by Dalarna County Council, Sweden at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Brush biopsy
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- 31 Aug 2019to 15 Jun 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting Public Dental Health for routine check-ups.
Who may be able to join
- Patients over 18 years of age
- Understand Swedish
Who cannot join
- Under 18 years of age
- Not understanding the Swedish language
- Previously mouth cancer diagnose
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Kristina Edman
Falun, Dalarna County, 79129
Public Dental Service
Falun, Dalarna County, 79129
About this study
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
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.
Read the 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
- Being tested
- Brush biopsy
- Keywords
- oral cancer screening
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brush biopsyDiagnostic test
Brush biopsy will be performed by dentists and dental hygienists
What is being measured
The primary outcome is the main question the study is designed to answer.
Brush biopsy
Presence of tumor markers and hrHPV in premalignant oral lesions. Each item is scored 0 (no tumor markers) and 1 (tumor markers)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start31 Aug 2019
- Primary completion31 Dec 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Edman, Dalarna County Council, Sweden
- Investigators
- Karin Gunnars Hellgren, Study chair, Public Dental Health Region Dalarna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081038
- Sponsor's protocol ID
- Oral cancer screening
- Acronym
- mouthcancer
- Status last verified
- Jun 2023
- First submitted
- 31 Aug 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04081038
- Acronym / sponsor ID
- mouthcancer / Oral cancer screening
- Conditions
- Oral Cancer
- Keywords
- oral cancer screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting Public Dental Health for routine check-ups.
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Understand Swedish
Key exclusion criteria (3 listed)
- Under 18 years of age
- Not understanding the Swedish language
- Previously mouth cancer diagnose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brush biopsyBrush biopsy will be performed by dentists and dental hygienists | Diagnostic test | – |
Primary outcome
Brush biopsy
Time frame: 1 year
Presence of tumor markers and hrHPV in premalignant oral lesions. Each item is scored 0 (no tumor markers) and 1 (tumor markers)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Gunnars Hellgren study chair
Public Dental Health Region Dalarna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by Dalarna County Council, Sweden at 2 sites in Sweden.
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 2 inclusion and 3 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Brush biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.