Oral Health KnowledgeNCT05917548
Oral Health Promotion Mediated by Teledentistry in Community-dwelling Older Adults of La Araucanía Region, Chile
A study testing Teledentistry oral health promotion and Face-to-Face oral health promotion in people with Oral Health Knowledge and Oral Health Attitudes, run by Fernanda Muñoz Sepúlveda at 1 site in Chile.
Trial summary
The goal of this randomized clinical trial is to compare the knowledge, attitudes, and oral health self-efficacy in self-sufficient elders aged over 60 years of 4 cities of La Araucanía región, Chile. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health Knowledge, Oral Health Attitudes, Oral Health Self-efficacy
- What is being tested?
- Teledentistry oral health promotion and Face-to-Face oral health promotion
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChile
- Study dates
- 3 Mar 2023to 14 Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over 60 years of age residing in La Araucanía Region
- Self-valent (Barthel index ≥ 90)
- With access to a smartphone and internet
- Ability to follow instructions and adequate mobility to go up to a mobile dental clinic.
Who cannot join
- Subjects with cognitive impairment (Folstein Mini-Mental ≤ 24)
- Totally edentulous
- Those who do not use WhatsApp
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Pilot Implementation of an Oral Health Promotion Strategy Mediated by Teledentistry Focused on Community-dwelling Older Adults of the La Araucanía Region of Chile
The goal of this randomized clinical trial is to compare the knowledge, attitudes, and oral health self-efficacy in self-sufficient elders aged over 60 years of 4 cities of La Araucanía región, Chile.
The main questions it aims to answer are:
Read more
- Can the development and implementation of a teledentistry strategy focused on community-dwelling older adults of the La Araucanía region improve participants' knowledge, attitudes, and self-efficacy in oral health?
- Could this teledentistry strategy have acceptability greater than 80%?
Participants will receive a dental-medical-geriatric diagnosis in a mobile dental clinic supported by a web platform called Teleplatform of Geriatric Dental Specialties (TEGO) and individual oral health education.
The researchers will compare a comparison group that will receive face-to-face individual oral health education with an intervention group, called tele-education group, that will receive educational reinforcement through a teledentistry strategy mediated by oral health educational videos sent via WhatsApp; to see if there are differences in the knowledge, attitudes, and oral health self-efficacy between the groups.
Read the detailed description
Access to oral health promotion for the elderly has been limited during their lifetime. The purpose of this study is the development and pilot implementation of an oral health promotion strategy mediated by teledentistry focused on community-dwelling older adults of the La Araucanía region. To this end, a randomized clinical trial is proposed with pre- and post-intervention tests to be carried out in a sample (n:120) of people over 60 years of age from 4 cities in this region. Both groups will undergo a dental-medical-geriatric diagnosis in a mobile dental clinic supported by a web platform called Teleplatform of Geriatric Dental Specialties (TEGO) and individual oral health education. The intervention group will also receive educational reinforcement through oral health videos sent via WhatsApp (Tele-education). The strategy will be evaluated through a questionnaire of knowledge, attitudes and self-efficacy in oral health that will be applied before and after the interventions received by both groups. The acceptability of the tele-educational strategy will be assessed. The statistical analysis contemplates the description of the sociodemographic profiles of the participants and the acceptability perceived by those who make up the tele-education group. The average of the scores obtained in the pre and post-test of the questionnaire will be compared within each group through the T-test for related samples and the average of the final scores will be compared between both groups through the T-test for independent samples. Likewise, the relationship between the post-test results, sociodemographic variables, and clinical variables will be evaluated through the Pearson Correlation Coefficient. A value of p < 0.05 was chosen as the threshold for significance.
- Being tested
- Teledentistry oral health promotion, Face-to-Face oral health promotion
- Keywords
- Teledentistry, Oral health promotion, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teledentistry oral health promotionDevice
Educational videos specially designed and validated for elderly (duration 4 to 6 minutes each one)
Face-to-Face oral health promotionBehavioural
Standardized PowerPoint presentation of 15 minutes about the most common or dangerous oral diseases (dental caries, periodontal disease and oral cancer), and toothbrushing and flossing practice in dental models
| Study group | Role | What they receive |
|---|---|---|
| Tele-education | Experimental | The tele-education group will receive the same intervention as the comparison group with an educational reinforcement mediated by teledentistry. This intervention consists of 4 educational videos, designed for the elderly, promoting correct toothbrushing and flossing, detection, and prevention of dental caries, periodontal disease, and oral cancer. These four videos were sent via WhatsApp. Receives: Device: Teledentistry oral health promotion; Behavioral: Face-to-Face oral health promotion |
| Comparison | Active comparator | The comparison group receive a medical-dental-geriatric diagnosis and face-to-face standardized education via powerpoint presentation and use of dental models for the promotion of correct toothbrushing and flossing, detection, and prevention of dental caries, periodontal disease, and oral cancer. Receives: Behavioral: Face-to-Face oral health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oral health knowledge
Questionnaire of 38 items focused on identifying signs and symptoms of dental caries, periodontal disease, and oral cancer, as well as preventive measures for each condition. The responses for signs and symptoms were quantified using a 'Yes' , 'I don't know' or 'No' scale, while preventive measures were ranked on a 5-point scale ranging from 'Very important to 'Not at all important
Measured: Change from baseline oral health knowledges at 6 weeks
Change in oral health attitudes
Attitudes were measured via a 5-point scale, which evaluated seven items associated with the inevitability of oral disease in the elderly, the value of keeping natural teeth, and the effectiveness of preventive behaviors
Measured: Change from baseline oral health attitudes at 6 weeks
Change in oral health self-efficacy
Oral Health self-efficacy scale to assess the individual's confidence in their ability to prevent oral diseases. This survey has 8 items under the subordinate categories of oral and general health self-efficacy, six and two questions respectively. All of the eight items had to be rated along a five-point Likert scale comprising Not at all Confident, Not confident, Neither confident nor unconfident, Confident, and Strongly Confident ratings.
Measured: Change from baseline oral health self-efficacy at 6 weeks
Secondary outcomes (3)
Acceptability: Utility of the teledentistry intervention
The utility of each video was assesed via a 4-point scale
Measured: 2 days after sending each video
Acceptability: Dropout rate
Percentage withdrawal of study participants
Measured: Change from baseline up to 6 weeks
Acceptability: Recomendation
Binary question with a yes or no answer on whether you would recommend this type of care and promotion of oral health to friends and/or family
Measured: After 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start3 Mar 2023
- Primary completion30 Aug 2023
- Study completion14 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Health KnowledgeStudies 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
- Model description
- The participants were contacted via phone calls for enrolment in TEGO platform where the pre-test of knowledge, attitudes and oral health self-efficacy was applied. Then, they were scheduled for medical-dental-geriatric diagnosis in a mobile dental clinic where all receive a standardized face-to-face oral health individual education. The investigator in charge of sending the videos performed age-stratified randomization in every city of the study using a random number generator function of the Epidat 4.2 program for the allocation of the participants in comparison or intervention groups. The videos were sent to the participants in the intervention group, this information is masked for the dental care providers and for the outcome assessor. 6 weeks later the face-to-face intervention both groups were assessed in with the post-test via phone call.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernanda Muñoz Sepúlveda
- Sponsor type
- University, hospital or other
- Collaborators
- Subvención Presidencial, Ministerio de Hacienda, Chile, Centro Interuniversitario de Envejecimiento Saludable (CIES), Beca de Postgrado Magíster Nacional, ANID
- Responsible party
- Sponsor-investigator, Fernanda Muñoz Sepúlveda, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917548
- Sponsor's protocol ID
- 082/22
- Status last verified
- Jan 2024
- First submitted
- 6 Jun 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD underlying the results will be shared in one publication
Publications
Beltran V, Flores M, Sanzana C, Munoz-Sepulveda F, Alvarado E, Venegas B, Molina JC, Rueda-Velasquez S, von Marttens A. Tooth Loss and Caries Experience of Elderly Chileans in the Context of the COVID-19 Pandemic in Five Regions of Chile. Int J Environ Res Public Health. 2023 Feb 9;20(4):3001. doi: 10.3390/ijerph20043001.
PubMed 36833696Beltran V, von Marttens A, Acuna-Mardones P, Sanzana-Luengo C, Rueda-Velasquez SJ, Alvarado E, Flores M, Cerda A, Venegas B. Implementation of a Teledentistry Platform for Dental Emergencies for the Elderly in the Context of the COVID-19 Pandemic in Chile. Biomed Res Int. 2022 Mar 22;2022:6889285. doi: 10.1155/2022/6889285. eCollection 2022.
PubMed 35330690Munoz-Sepulveda F, Beltran V, von Marttens A, Navarro P, Acevedo C, Marino R, Chaparro A, Lopez L. WhatsApp-Supported Teledentistry to Reinforce Oral Health Promotion Among Older Adults Residing in Rural and Urban Areas: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 May 15;14:e71251. doi: 10.2196/71251.
PubMed 42139689
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Implementation of an Oral Health Promotion Strategy Mediated by Teledentistry Focused on Community-dwelling Older Adults of the La Araucanía Region of Chile
- ClinicalTrials.gov ID
- NCT05917548
- Acronym / sponsor ID
- 082/22
- Keywords
- Teledentistry, Oral health promotion, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Fernanda Muñoz SepúlvedaUniversity, hospital or other
- Collaborators
- Subvención Presidencial, Ministerio de Hacienda, Chile, Centro Interuniversitario de Envejecimiento Saludable (CIES), Beca de Postgrado Magíster Nacional, ANID
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 14 Oct 2023 (actual)
- First posted
- 26 Jun 2023 (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 randomized clinical trial is to compare the knowledge, attitudes, and oral health self-efficacy in self-sufficient elders aged over 60 years of 4 cities of La Araucanía región, Chile.
The main questions it aims to answer are:
- Can the development and implementation of a teledentistry strategy focused on community-dwelling older adults of the La Araucanía region improve participants' knowledge, attitudes, and self-efficacy in oral health?
- Could this teledentistry strategy have acceptability greater than 80%?
Participants will receive a dental-medical-geriatric diagnosis in a mobile dental clinic supported by a web platform called Teleplatform of Geriatric Dental Specialties (TEGO) and individual oral health education.
The researchers will compare a comparison group that will receive face-to-face individual oral health education with an intervention group, called tele-education group, that will receive educational reinforcement through a teledentistry strategy mediated by oral health educational videos sent via WhatsApp; to see if there are differences in the knowledge, attitudes, and oral health self-efficacy between the groups.
Detailed description
Access to oral health promotion for the elderly has been limited during their lifetime. The purpose of this study is the development and pilot implementation of an oral health promotion strategy mediated by teledentistry focused on community-dwelling older adults of the La Araucanía region. To this end, a randomized clinical trial is proposed with pre- and post-intervention tests to be carried out in a sample (n:120) of people over 60 years of age from 4 cities in this region. Both groups will undergo a dental-medical-geriatric diagnosis in a mobile dental clinic supported by a web platform called Teleplatform of Geriatric Dental Specialties (TEGO) and individual oral health education. The intervention group will also receive educational reinforcement through oral health videos sent via WhatsApp (Tele-education). The strategy will be evaluated through a questionnaire of knowledge, attitudes and self-efficacy in oral health that will be applied before and after the interventions received by both groups. The acceptability of the tele-educational strategy will be assessed. The statistical analysis contemplates the description of the sociodemographic profiles of the participants and the acceptability perceived by those who make up the tele-education group. The average of the scores obtained in the pre and post-test of the questionnaire will be compared within each group through the T-test for related samples and the average of the final scores will be compared between both groups through the T-test for independent samples. Likewise, the relationship between the post-test results, sociodemographic variables, and clinical variables will be evaluated through the Pearson Correlation Coefficient. A value of p < 0.05 was chosen as the threshold for significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants were contacted via phone calls for enrolment in TEGO platform where the pre-test of knowledge, attitudes and oral health self-efficacy was applied. Then, they were scheduled for medical-dental-geriatric diagnosis in a mobile dental clinic where all receive a standardized face-to-face oral health individual education. The investigator in charge of sending the videos performed age-stratified randomization in every city of the study using a random number generator function of the Epidat 4.2 program for the allocation of the participants in comparison or intervention groups. The videos were sent to the participants in the intervention group, this information is masked for the dental care providers and for the outcome assessor. 6 weeks later the face-to-face intervention both groups were assessed in with the post-test via phone call.
| Arm | Type | Receives |
|---|---|---|
| Tele-education | Experimental | Device: Teledentistry oral health promotion, Behavioral: Face-to-Face oral health promotionThe tele-education group will receive the same intervention as the comparison group with an educational reinforcement mediated by teledentistry. This intervention consists of 4 educational videos, designed for the elderly, promoting correct toothbrushing and flossing, detection, and prevention of dental caries, periodontal disease, and oral cancer. These four videos were sent via WhatsApp. |
| Comparison | Active comparator | Behavioral: Face-to-Face oral health promotionThe comparison group receive a medical-dental-geriatric diagnosis and face-to-face standardized education via powerpoint presentation and use of dental models for the promotion of correct toothbrushing and flossing, detection, and prevention of dental caries, periodontal disease, and oral cancer. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 60 years of age residing in La Araucanía Region
- Self-valent (Barthel index ≥ 90)
- With access to a smartphone and internet
- Ability to follow instructions and adequate mobility to go up to a mobile dental clinic.
Key exclusion criteria (3 listed)
- Subjects with cognitive impairment (Folstein Mini-Mental ≤ 24)
- Totally edentulous
- Those who do not use WhatsApp
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 |
|---|---|---|
| Teledentistry oral health promotionEducational videos specially designed and validated for elderly (duration 4 to 6 minutes each one) | Device | Tele-education |
| Face-to-Face oral health promotionStandardized PowerPoint presentation of 15 minutes about the most common or dangerous oral diseases (dental caries, periodontal disease and oral cancer), and toothbrushing and flossing practice in dental models | Behavioural | Comparison, Tele-education |
Primary outcome
Change in oral health knowledge
Time frame: Change from baseline oral health knowledges at 6 weeks
Questionnaire of 38 items focused on identifying signs and symptoms of dental caries, periodontal disease, and oral cancer, as well as preventive measures for each condition. The responses for signs and symptoms were quantified using a 'Yes' , 'I don't know' or 'No' scale, while preventive measures were ranked on a 5-point scale ranging from 'Very important to 'Not at all important
Change in oral health attitudes
Time frame: Change from baseline oral health attitudes at 6 weeks
Attitudes were measured via a 5-point scale, which evaluated seven items associated with the inevitability of oral disease in the elderly, the value of keeping natural teeth, and the effectiveness of preventive behaviors
Change in oral health self-efficacy
Time frame: Change from baseline oral health self-efficacy at 6 weeks
Oral Health self-efficacy scale to assess the individual's confidence in their ability to prevent oral diseases. This survey has 8 items under the subordinate categories of oral and general health self-efficacy, six and two questions respectively. All of the eight items had to be rated along a five-point Likert scale comprising Not at all Confident, Not confident, Neither confident nor unconfident, Confident, and Strongly Confident ratings.
3 secondary outcomes
Acceptability: Utility of the teledentistry intervention
Time frame: 2 days after sending each video
Acceptability: Dropout rate
Time frame: Change from baseline up to 6 weeks
Acceptability: Recomendation
Time frame: After 6 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 3 Jan 2024.
- Background: PubMed 36833696Beltran V, Flores M, Sanzana C, Munoz-Sepulveda F, Alvarado E, Venegas B, Molina JC, Rueda-Velasquez S, von Marttens A. Tooth Loss and Caries Experience of Elderly Chileans in the Context of the COVID-19 Pandemic in Five Regions of Chile. Int J Environ Res Public Health. 2023 Feb 9;20(4):3001. doi: 10.3390/ijerph20043001.
- Background: PubMed 35330690Beltran V, von Marttens A, Acuna-Mardones P, Sanzana-Luengo C, Rueda-Velasquez SJ, Alvarado E, Flores M, Cerda A, Venegas B. Implementation of a Teledentistry Platform for Dental Emergencies for the Elderly in the Context of the COVID-19 Pandemic in Chile. Biomed Res Int. 2022 Mar 22;2022:6889285. doi: 10.1155/2022/6889285. eCollection 2022.
- Derived from this study: PubMed 42139689Munoz-Sepulveda F, Beltran V, von Marttens A, Navarro P, Acevedo C, Marino R, Chaparro A, Lopez L. WhatsApp-Supported Teledentistry to Reinforce Oral Health Promotion Among Older Adults Residing in Rural and Urban Areas: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 May 15;14:e71251. doi: 10.2196/71251.
- Individual participant dataSharing planned: Yes. All IPD underlying the results will be shared in one publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teledentistry oral health promotion and Face-to-Face oral health promotion in people with Oral Health Knowledge and Oral Health Attitudes, run by Fernanda Muñoz Sepúlveda 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 3 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 3 Jan 2024. 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 oral health knowledge (time frame: Change from baseline oral health knowledges at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05917548, which also lists 3 linked publications.
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 3 Jan 2024.