- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04081038
Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies (mouthcancer)
June 15, 2023 updated by: Kristina Edman, Dalarna County Council, Sweden
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.
Study Overview
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
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dalarna
-
Falun, Dalarna, Sweden, 79129
- Kristina Edman
-
Falun, Dalarna, Sweden, 79129
- Public Dental Service
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients visiting Public Dental Health for routine check-ups.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Karin Gunnars Hellgren, Public Dental Health Region Dalarna
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2019
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
June 15, 2023
Study Registration Dates
First Submitted
August 31, 2019
First Submitted That Met QC Criteria
September 4, 2019
First Posted (Actual)
September 6, 2019
Study Record Updates
Last Update Posted (Estimated)
June 16, 2023
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Oral cancer screening
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Cancer
-
Royal Surrey County Hospital NHS Foundation TrustCompleted
-
Centre Francois BaclesseTerminatedCancer | Cognitive Function | Compliance | Oral TherapiesFrance
-
University of WashingtonBlaze Bioscience Inc.RecruitingStage III Lip and Oral Cavity Cancer AJCC v8 | Oral Cavity Squamous Cell Carcinoma | Stage I Lip and Oral Cavity Cancer AJCC v8 | Stage II Lip and Oral Cavity Cancer AJCC v8 | Stage IVA Lip and Oral Cavity Cancer AJCC v8United States
-
National Cancer Institute (NCI)CompletedLip and Oral Cavity Cancer | Oropharyngeal Cancer | Tongue Cancer | Oral LeukoplakiaUnited States
-
National Cancer Institute (NCI)CompletedLip and Oral Cavity Cancer | Oropharyngeal Cancer | Tongue Cancer | Stage 0 Lip and Oral Cavity Cancer | Stage 0 Oropharyngeal CancerUnited States
-
Dana-Farber Cancer InstituteCompletedBreast Cancer | Gastrointestinal Cancer | Oral Cancer Directed Therapy | Oral ChemotherapyUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedTongue Cancer | Lip and Oral Cavity Squamous Cell Carcinoma | Oral Cavity Verrucous Carcinoma | Stage 0 Lip and Oral Cavity CancerUnited States
-
University of British ColumbiaRecruiting
-
Istituto Scientifico Romagnolo per lo Studio e...Kessler FoundationUnknownCancer | Oral Drug AdministrationItaly
-
Centre Francois BaclesseLigue contre le cancer, FranceCompletedManagement of Oral Care and Cancer in Palliative SituationFrance
Clinical Trials on Brush biopsy
-
CDx DiagnosticsRambam Health Care CampusWithdrawnLaryngopharyngeal Reflux | Laryngeal Disease | Laryngeal Tumor
-
Hadassah Medical OrganizationUnknownPrimary Ciliary DyskinesiaIsrael
-
M.D. Anderson Cancer CenterNational Institutes of Health (NIH); William Marsh Rice UniversityWithdrawnHead and Neck Cancer
-
University of UlmHeidelberg UniversityCompleted
-
Assiut UniversityNot yet recruitingDisorder of Pleura and Pleural Cavity
-
Weill Medical College of Cornell UniversityWithdrawn
-
Princess Margaret Hospital, Hong KongRecruiting
-
University of BaghdadCompleted
-
Mayo ClinicCompleted