Can a health intervention improve knowledge of oral cancer in dentists and dental students?
| ISRCTN | ISRCTN48708543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48708543 |
| Secondary identifying numbers | Colgate-ACFO 2021 |
- Submission date
- 05/04/2022
- Registration date
- 25/05/2022
- Last edited
- 18/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Oral cancer is a rapidly evolving and aggressive disease, to which various population groups are exposed, being the sixth most common cause of cancer-related death worldwide.
Oral cancer is associated with multiple factors. Some of them are largely modifiable. They are habits and lifestyles that can become self-managed. Knowing different aspects of oral cancer could improve the attitudes and practices of health professionals, which can lead to early diagnosis.
The purpose of this study is to determine the efficacy of an educational intervention in the knowledge, attitudes and practice of dentists and dental students about oral cancer.
Who can participate?
Dentists that teach at dental schools in Colombia and dental students.
What does the study involve?
Participants will be randomly allocated to receive an educational intervention website or leaflet, or no intervention. Knowledge, attitudes and practice are assessed before the intervention and 2 months after.
What are the possible benefits and risks of participating?
None
Where is the study run form?
Universidad Santo Tomás campus Floridablanca (Colombia)
When is the study starting and how long is it expected to run for?
August 2021 to August 2023
Who is funding the study?
Colgate-Palmolive (USA)
Asociación Colombiana de Facultades de Odontología, ACFO (Colombia)
Who is the main contact?
Gloria Aranzazu, gloria.aranzazu@ustabuca.edu.co
Contact information
Principal Investigator
Cra. 27 Nº 180 - 395
Universidad Santo Tomás campus Floridablanca
Facultad de Odontología
Floridablanca
681003
Colombia
 ORCID ID |
0000-0002-3295-6133 |
|---|---|
| Phone | +57 3168276105 |
| gloria.aranzazu@ustabuca.edu.co |
Study information
| Study design | Multicenter interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual, University/medical school/dental school |
| Study type | Other, Efficacy |
| Participant information sheet | 41500_PIS.pdf |
| Scientific title | Efficacy of a health intervention in oral cancer aimed at dentists and dental students |
| Study acronym | ORCAKNOW |
| Study objectives | The intervention groups will have better knowledge, attitude and practice scores (KAP) than the control group |
| Ethics approval(s) | Approved 25/08/2021, Santo Tomás University Bucaramanga-Colombia Research Ethics Committee (Cra 18 nº 9-27 Bucaramanga-Colombia; no telephone number provided; comite.etica@ustabuca.edu.co), ref: Código 0161-2021 |
| Health condition(s) or problem(s) studied | Oral cancer knowledge, attitude and practice in dentists and dental students. |
| Intervention | Group 0. No intervention Group 1. Intervention website Group 2. Intervention leaflet Participants will be randomized in to the groups by aleatory number list, 66 participant by each of 10 centers (dental school or hospital) 33 dentist and 33 clinical students (11dentist and student will be include in each group). Time between initial KAP evaluation and final, will be 2 months. |
| Intervention type | Other |
| Primary outcome measure | 1. Knowledge measured using questionnaire score before and 2 months after the intervention. 2. Attitude measured using questionnaire score before and 2 months after the intervention 3. Practice measured using questionnaire score before and 2 months after the intervention |
| Secondary outcome measures | Demographic information measured by questionnaire at initial recruitment: 1. Age (years) 2. Gender 3. Occupation (dentist or student) 4. Degree (student, general dentist or specialist) 5. City 6. University 7. Years of dental practice |
| Overall study start date | 25/08/2021 |
| Completion date | 01/08/2023 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 10 clusters and 66 participants in each cluster |
| Total final enrolment | 598 |
| Key inclusion criteria | 1. Dentist who teaches at a dental school in Colombia 2. Dental student in clinical practice (semester 6-10) in Colombia |
| Key exclusion criteria | Dentist with oral medicine or oral pathology practice |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 30/08/2023 |
Locations
Countries of recruitment
- Colombia
Study participating centres
Floridablanca
681003
Colombia
Manizales
170001
Colombia
Medellín
050010
Colombia
Bogotá
110121
Colombia
Bogotá
110231
Colombia
Cartagena de Indias-Bolivar
130001
Colombia
Barranquilla
00000
Colombia
Bogotá
110111
Colombia
Santa Marta
470004
Colombia
Cali
760043
Colombia
Medellín
50031
Colombia
Bogotá D.C.
11001
Colombia
Sponsor information
University/education
Cra. 18 No. 9 - 27
Bucaramanga
681003
Colombia
| Phone | +57 607-6985858 |
|---|---|
| investigacion@ustabuca.edu.co | |
| Website | http://www.ustabuca.edu.co |
"ROR" |
https://ror.org/02vbtzd72 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Individual data can be available on request from gloria.aranzazu@ustabuca.edu.co |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 13/04/2022 | No | Yes | ||
| Protocol file | 13/04/2022 | No | No | ||
| Results article | 18/06/2025 | 18/06/2025 | Yes | No |
Additional files
Editorial Notes
18/06/2025: Publication reference added.
17/09/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The intention to publish date was changed from 30/01/2024 to 30/01/2025.
02/06/2023: The recruitment end date was changed from 01/06/2023 to 30/08/2023. Universidad Nacional de Colombia was added as a study participating centre.
13/04/2022: Trial's existence confirmed by the Santo Tomás University Bucaramanga-Colombia Research Ethics Committee.
