Dental Hygienists and Dentists as Providers of Oral Mucosa Screening and Brush Biopsies

NCT04081038 | Completed

• 1 other identifier: Oral cancer screening
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oral Cancer

Keywords

oral cancer screening

Outcome Measures

Primary Outcomes (1)

• Brush biopsy

  Presence of tumor markers and hrHPV in premalignant oral lesions. Each item is scored 0 (no tumor markers) and 1 (tumor markers)

  1 year

Interventions

Brush biopsy DIAGNOSTIC_TEST

Brush biopsy will be performed by dentists and dental hygienists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting Public Dental Health for routine check-ups.

You may qualify if:

• Patients over 18 years of age
• Understand Swedish

You may not qualify if:

• Under 18 years of age
• Not understanding the Swedish language
• Previously mouth cancer diagnose

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead

Study Sites (2)

Kristina Edman

Falun, Dalarna County, 79129, Sweden

Location

Public Dental Service

Falun, Dalarna County, 79129, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Brush samples will be performed and the lesions obtained, analyzed for hrHPV and the presence of malignant cells or malignant associated cells.

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Karin Gunnars Hellgren

  Public Dental Health Region Dalarna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: September 6, 2019
• Study Start: August 31, 2019
• Primary Completion: December 31, 2022
• Study Completion: June 15, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

SE (2)