- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04079491
Intra and Extra Oral Inspection of Oral Mucosa
Dental Hygienists and Oral Mucosal Inspection - Extent, Knowledge and Perceived Barriers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Sweden, education and training in intraoral inspection of the oral mucosa is a part of the curriculum in dental hygienists education, so there is an expectation that the dental hygienist routinely perform tactile and visual intraoral inspections in practice. However, DH are not trained in extra oral inspection and 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 DH are capable to identify risk behaviors, such as alcohol and smoking, and recommend, and offer smoking cessation or refer the patient to a certified profession for smoking cessation.
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. Tumors caused by tobacco and alcohol are constant [7-9]. 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. The 5 year survival of oral cancer in Sweden is 55 % and only 3-4% in advanced cases. The etiology is hrHPV, exposure to tobacco and alcohol in 65% [13] 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. 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. Being aware of the increasing number of head, neck, and oral tumors we need to highlight the importance of inspection of the oral mucosa.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Kristina Edman
- Phone Number: +46 23 490155
- Email: kristina.edman@regiondalarna.se
Study Locations
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Dalarna
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Falun, Dalarna, Sweden, 79129
- Public Dental Service
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Registered dental hygienists members in the Swedish trade union
Exclusion criteria:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
dental hygienists
all dental hygienists members in the trade union for dental hygienists
|
A web-based questionnaire will be send by the trade union for dental hygienists
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of intra and extra oral inspection of the oral mucosa
Time Frame: baseline
|
A 27-item survey instrument using Likert-type and open-ended questions, constructed by dental hygienists and used in Canada, College of dental hygienists Nova Scotia, Canada is used.
Frequency and comprehensiveness of intra- and extra-oral inspection is investigated and participants can answer always, usually, sometimes, rarely or never.
|
baseline
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Barriers that might prevent dental hygienists from performing intra and oral inspection of the oral mucosa.
Time Frame: baseline
|
From a drop down meny participants get seven alternative barriers; • Someone else in my office performs the exam [if selected drop down menu options appear: dentist, dental assistant, do not know, other
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Karin Gunnars Hellgren, Public Dental Health Region of Dalarna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Head and Neck Neoplasms
- Stomatognathic Diseases
- Mouth Diseases
- Pathological Conditions, Anatomical
- Skin Diseases, Papulosquamous
- Precancerous Conditions
- Mouth Neoplasms
- Lichenoid Eruptions
- Leukoplakia
- Leukoplakia, Oral
- Lichen Planus, Oral
- Lichen Planus
- Erythroplasia
Other Study ID Numbers
- Inspection oral mucosa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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