Oral CancerNCT07275411
mHealth App for Oral Hygiene and Cancer Awareness in Older Adults
A study testing Mobile Oral Health Education App in people with Oral Cancer and Oral Health Knowledge, Attitude and Practice Among Patients, run by University of Chile at 1 site in Chile.
Trial summary
The goal of this clinical trial is to learn whether a mobile app with educational videos and serious games is more effective than a video-only version of the app to improve knowledge, attitudes, and practices about oral cancer and oral hygiene in older adults. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Oral Health Knowledge, Attitude and Practice Among Patients, Older Adults
- What is being tested?
- Mobile Oral Health Education App
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChile
- Study dates
- 2 May 2024to 11 Nov 2024
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 60 years and older.
- Completed dental treatment at the Dental Clinic of the Faculty of Dentistry, University of Chile, during 2023 and 2024.
- Own a smartphone with Android operating system.
- Regular users of at least one social media platform (e.g., WhatsApp, Instagram, Facebook).
Who cannot join
- Older adults with self-reported uncorrected visual or auditory sensory deficits resulting in total blindness or deafness.
- Older adults with cognitive impairment, defined as a score of 13 or lower on the abbreviated Mini-Mental State Examination (MMSE) (maximum score 19).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-education Through a New Mobile Application to Improve Oral Cancer Knowledge and Oral Hygiene in Older Adults
The goal of this clinical trial is to learn whether a mobile app with educational videos and serious games is more effective than a video-only version of the app to improve knowledge, attitudes, and practices about oral cancer and oral hygiene in older adults.
The study also aims to evaluate the usability of the app and the impact of the intervention on performing oral self-examination.
Read more
The main questions it aims to answer are:
- - Does the version of the app with videos and serious games lead to greater improvement in oral cancer knowledge than the video-only version?
- - Are there differences in attitudes and self-examination practices between the two groups after using the app?
- - How frequently and consistently do participants use the app during the study period, and how much do they interact with the educational videos and serious games?
- - Are there differences in outcomes by sex or education level?
Participants will:
Be adults aged 60 and more receiving care at the Dental Clinic of the University of Chile
Be randomly assigned to use one of two versions of the same app:
- Group A: Access to educational videos and serious games
- Group B: Access to educational videos only
Use the app for 4 weeks
Answer a questionnaire before starting, after 2 weeks, and after 4 weeks
Perform an oral self-examination at week 4, which will be evaluated using a checklist
This trial will help determine whether mobile tele-education tools, especially those that include interactive features like serious games, are effective and acceptable ways to improve oral health education in older adults.
- Being tested
- Mobile Oral Health Education App
- Medical subject headings
- Mouth Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Oral Health Education AppBehavioural
This intervention consists of a mobile application designed to improve oral health knowledge, attitudes, and practices among older adults. The app includes educational videos about oral hygiene and oral cancer. In the experimental group, the app also incorporates interactive serious games to reinforce learning and promote oral self-examination. In the active comparator group, participants have access only to the educational videos within the same app. The intervention targets individuals aged 60 to 70 years and is evaluated over a 4-week period through questionnaires and observation of oral self-examination practices.
| Study group | Role | What they receive |
|---|---|---|
| Serious Games Group | Experimental | Participants receive an oral health mobile application with educational videos and serious games designed to improve knowledge and self-examination practices. Receives: Behavioral: Mobile Oral Health Education App |
| Video-Only Group | Active comparator | Participants receive an oral health mobile application with educational videos only, without interactive components. Receives: Behavioral: Mobile Oral Health Education App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge, attitudes about oral cancer and oral hygiene, and performance of oral self-examination in older adults using a mobile educational application.
increasing participants' knowledge and attitudes regarding oral cancer and oral hygiene, as well as their ability to perform oral self-examination. Knowledge and attitudes are measured using a structured questionnaire administered at baseline, 2 weeks, and 4 weeks. Oral self-examination practices are evaluated at 4 weeks using a standardized checklist verifying the correct performance of five key steps. Comparisons are made between the group using videos and serious games and the group using videos only.
Measured: Baseline, 2 weeks, and 4 weeks after the start of the intervention.
Secondary outcomes (1)
Usability of the mobile oral health education application
Evaluates participant use and engagement with the mobile app by analyzing interaction logs recorded within the app over the 4-week intervention period. Usage data are compared between the group using videos plus serious games and the group using videos only.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start2 May 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de La Frontera
- Responsible party
- Principal investigator, Iris Espinoza Santander, University of Chile
- Investigators
- Iris Lucia Espinoza-Santander, PhD in Public Health, Principal investigator, Departament of Pathology and Oral Medicine, Faculty of Dentistry, University of ChileConstanza Beatriz Morales-Gómez, Master's Degree in Science, Study chair, Departament of Pathology and Oral Medicine, Faculty of Dentistry, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275411
- Sponsor's protocol ID
- CIES009
- Status last verified
- Jun 2025
- First submitted
- 27 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-education Through a New Mobile Application to Improve Oral Cancer Knowledge and Oral Hygiene in Older Adults
- ClinicalTrials.gov ID
- NCT07275411
- Acronym / sponsor ID
- CIES009
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Universidad de La Frontera
- Study start
- 2 May 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 10 Dec 2025 (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.
The goal of this clinical trial is to learn whether a mobile app with educational videos and serious games is more effective than a video-only version of the app to improve knowledge, attitudes, and practices about oral cancer and oral hygiene in older adults.
The study also aims to evaluate the usability of the app and the impact of the intervention on performing oral self-examination.
The main questions it aims to answer are:
- - Does the version of the app with videos and serious games lead to greater improvement in oral cancer knowledge than the video-only version?
- - Are there differences in attitudes and self-examination practices between the two groups after using the app?
- - How frequently and consistently do participants use the app during the study period, and how much do they interact with the educational videos and serious games?
- - Are there differences in outcomes by sex or education level?
Participants will:
Be adults aged 60 and more receiving care at the Dental Clinic of the University of Chile
Be randomly assigned to use one of two versions of the same app:
- Group A: Access to educational videos and serious games
- Group B: Access to educational videos only
Use the app for 4 weeks
Answer a questionnaire before starting, after 2 weeks, and after 4 weeks
Perform an oral self-examination at week 4, which will be evaluated using a checklist
This trial will help determine whether mobile tele-education tools, especially those that include interactive features like serious games, are effective and acceptable ways to improve oral health education in older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious Games Group | Experimental | Behavioral: Mobile Oral Health Education AppParticipants receive an oral health mobile application with educational videos and serious games designed to improve knowledge and self-examination practices. |
| Video-Only Group | Active comparator | Behavioral: Mobile Oral Health Education AppParticipants receive an oral health mobile application with educational videos only, without interactive components. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 60 years and older.
- Completed dental treatment at the Dental Clinic of the Faculty of Dentistry, University of Chile, during 2023 and 2024.
- Own a smartphone with Android operating system.
- Regular users of at least one social media platform (e.g., WhatsApp, Instagram, Facebook).
Key exclusion criteria (2 listed)
- Older adults with self-reported uncorrected visual or auditory sensory deficits resulting in total blindness or deafness.
- Older adults with cognitive impairment, defined as a score of 13 or lower on the abbreviated Mini-Mental State Examination (MMSE) (maximum score 19).
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 |
|---|---|---|
| Mobile Oral Health Education AppThis intervention consists of a mobile application designed to improve oral health knowledge, attitudes, and practices among older adults. The app includes educational videos about oral hygiene and oral cancer. In the experimental group, the app also incorporates interactive serious games to reinforce learning and promote oral self-examination. In the active comparator group, participants have access only to the educational videos within the same app. The intervention targets individuals aged 60 to 70 years and is evaluated over a 4-week period through questionnaires and observation of oral self-examination practices. | Behavioural | Serious Games Group, Video-Only Group |
Primary outcome
Change in knowledge, attitudes about oral cancer and oral hygiene, and performance of oral self-examination in older adults using a mobile educational application.
Time frame: Baseline, 2 weeks, and 4 weeks after the start of the intervention.
increasing participants' knowledge and attitudes regarding oral cancer and oral hygiene, as well as their ability to perform oral self-examination. Knowledge and attitudes are measured using a structured questionnaire administered at baseline, 2 weeks, and 4 weeks. Oral self-examination practices are evaluated at 4 weeks using a standardized checklist verifying the correct performance of five key steps. Comparisons are made between the group using videos and serious games and the group using videos only.
1 secondary outcome
Usability of the mobile oral health education application
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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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.
Iris Lucia Espinoza-Santander, PhD in Public Health principal investigator
Departament of Pathology and Oral Medicine, Faculty of Dentistry, University of Chile
Constanza Beatriz Morales-Gómez, Master's Degree in Science study chair
Departament of Pathology and Oral Medicine, Faculty of Dentistry, University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Oral Health Education App in people with Oral Cancer and Oral Health Knowledge, Attitude and Practice Among Patients, run by University of Chile at 1 site in Chile.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 10 Dec 2025. 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 Chile. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in knowledge, attitudes about oral cancer and oral hygiene, and performance of oral self-examination in older adults using a mobile educational application. (time frame: Baseline, 2 weeks, and 4 weeks after the start of the intervention.). 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 10 Dec 2025.