Intra and Extra Oral Inspection of Oral Mucosa

February 14, 2023 updated by: Kristina Edman, Dalarna County Council, Sweden

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.

Study Overview

Status

Terminated

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

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Dalarna
      • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

  • Registered dental hygienists members in the Swedish trade union

Exclusion criteria:

-

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: 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
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Karin Gunnars Hellgren, Public Dental Health Region of 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)

February 1, 2020

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 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 (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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.

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