Oral Lichen PlanusNCT04079491
Intra and Extra Oral Inspection of Oral Mucosa
An observational study of Oral Lichen Planus and Oral Leukoplakia, run by Dalarna County Council, Sweden at 1 site in Sweden.
Trial summary
Dental health professionals have a responsibility to perform routine intra- and extraoral inspection on their patients for detecting abnormalities. As dental hygienists (DH) and dentist (D) often see their patients on a regular basis, they have the opportunity to provide this screening, and at an early stage detect… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Lichen Planus, Oral Leukoplakia, Erythroplakia
- What is being tested?
- questionnaire survey
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2020to 31 Jan 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All dental hygienists members in the trade union will be offered to participate
Who may be able to join
- Registered dental hygienists members in the Swedish trade union
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dental Hygienists and Oral Mucosal Inspection - Extent, Knowledge and Perceived Barriers
Dental health professionals have a responsibility to perform routine intra- and extraoral inspection on their patients for detecting abnormalities. As dental hygienists (DH) and dentist (D) often see their patients on a regular basis, they have the opportunity to provide this screening, and at an early stage detect abnormalities.
Read the 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.
- Conditions
- Oral Lichen Planus, Oral Leukoplakia, Erythroplakia
- Being tested
- questionnaire survey
- Keywords
- oral mucosal lesions, dental hygienist
- Medical subject headings
- Lichen Planus, Oral, Leukoplakia, Oral, Erythroplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire surveyOther
A web-based questionnaire will be send by the trade union for dental hygienists
| Study group | Role | What they receive |
|---|---|---|
| dental hygienists | all dental hygienists members in the trade union for dental hygienists Receives: Other: questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of intra and extra oral inspection of the oral mucosa
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.
Measured: baseline
Barriers that might prevent dental hygienists from performing intra and oral inspection of the oral mucosa.
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
- Lack of knowledge and/or skills to perform the exam
- Lack of time
- Concern about patient compliance
- Concern over remuneration for services
- Not sure if it is within the dental hygiene scope of practice
- Other
Measured: baseline
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 start1 Feb 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2023
Why it stopped: Poor responce
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
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 of Dalarna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079491
- Sponsor's protocol ID
- Inspection oral mucosa
- Status last verified
- Feb 2023
- First submitted
- 31 Aug 2019
- Last updated
- 16 Feb 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Hygienists and Oral Mucosal Inspection - Extent, Knowledge and Perceived Barriers
- ClinicalTrials.gov ID
- NCT04079491
- Acronym / sponsor ID
- Inspection oral mucosa
- Conditions
- Oral Lichen Planus, Oral Leukoplakia, Erythroplakia
- Keywords
- oral mucosal lesions, dental hygienist
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor responce
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 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.
Dental health professionals have a responsibility to perform routine intra- and extraoral inspection on their patients for detecting abnormalities. As dental hygienists (DH) and dentist (D) often see their patients on a regular basis, they have the opportunity to provide this screening, and at an early stage detect abnormalities.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dental hygienists | – | Other: questionnaire surveyall dental hygienists members in the trade union for dental hygienists |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All dental hygienists members in the trade union will be offered to participate
Key inclusion criteria (1 listed)
- Registered dental hygienists members in the Swedish trade union
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| questionnaire surveyA web-based questionnaire will be send by the trade union for dental hygienists | Other | dental hygienists |
Primary outcome
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.
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 * Lack of knowledge and/or skills to perform the exam * Lack of time * Concern about patient compliance * Concern over remuneration for services * Not sure if it is within the dental hygiene scope of practice * Other
Results and safety
The study was stopped early (reason given: Poor responce). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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 of Dalarna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus and Oral Leukoplakia, run by Dalarna County Council, Sweden at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Poor responce). Results are not available in the source record.
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?
Performance of intra and extra oral inspection of the oral mucosa (time frame: baseline). The study lists 2 primary outcomes in all. 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 16 Feb 2023.