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TerminatedNCT04079491Updated Feb 16, 2023

Intra and Extra Oral Inspection of Oral Mucosa

An observational study in Oral Lichen Planus, Oral Leukoplakia and Erythroplakia, sponsored by Dalarna County Council, Sweden. Terminated at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2023-02-16.

Sponsored by Dalarna County Council, Sweden · Observational

Why this study was terminated
Poor responce
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
70
Sex
All
01

Study 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 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.

02

Conditions studied

  • Oral Lichen Planus
  • Oral Leukoplakia
  • Erythroplakia

Keywords

  • oral mucosal lesions
  • dental hygienist
03

In context

Lichen Planus, Oral

142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.

This study's enrollment of 70 is close to the median of 75 across 38 observational studies indexed under Lichen Planus, Oral.

Browse Lichen Planus, Oral studies →

Lead sponsor

Dalarna County Council, Sweden is the lead sponsor of 28 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All dental hygienists members in the trade union will be offered to participate

Inclusion criteria

  • Registered dental hygienists members in the Swedish trade union

Exclusion criteria

Exclusion criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • dental hygienists

    all dental hygienists members in the trade union for dental hygienists

    Other: questionnaire survey

Interventions

  • Otherquestionnaire survey

    A web-based questionnaire will be send by the trade union for dental hygienists

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

  2. 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

    Time frame: baseline

07

Study locations

1 site
  • Public Dental Service
    Falun, Dalarna 79129, Sweden
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Jan 2022, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2019
First posted
Sep 6, 2019
StartActual
Feb 1, 2020
Primary completionActual
Jan 31, 2022
CompletionActual
Jan 31, 2023
Last update
Feb 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04079491
Lead sponsor
Dalarna County Council, Sweden
Responsible party
Kristina Edman (Principal Investigator, Dalarna County Council, Sweden) — Principal investigator
First posted
Sep 6, 2019
Start date
Feb 1, 2020
Primary completion
Jan 31, 2022
Completion
Jan 31, 2023
Last update
Feb 16, 2023

Study contacts

Karin Gunnars Hellgren
study chair · Public Dental Health Region of Dalarna

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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