- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917548
Oral Health Promotion Mediated by Teledentistry in Community-dwelling Older Adults of La Araucanía Region, Chile
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:
- 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
La Araucanía
-
Temuco, La Araucanía, Chile
- Clinica Dental Móvil TEGO-UFRO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects with cognitive impairment (Folstein Mini-Mental ≤ 24)
- Totally edentulous
- Those who do not use WhatsApp
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele-education
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.
|
Educational videos specially designed and validated for elderly (duration 4 to 6 minutes each one)
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
|
|
Active Comparator: Comparison
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 from baseline oral health knowledges at 6 weeks
|
|
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 from baseline oral health attitudes at 6 weeks
|
|
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.
|
Change from baseline oral health self-efficacy at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability: Utility of the teledentistry intervention
Time Frame: 2 days after sending each video
|
The utility of each video was assesed via a 4-point scale
|
2 days after sending each video
|
|
Acceptability: Dropout rate
Time Frame: Change from baseline up to 6 weeks
|
Percentage withdrawal of study participants
|
Change from baseline up to 6 weeks
|
|
Acceptability: Recomendation
Time Frame: After 6 weeks
|
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
|
After 6 weeks
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Beltran 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 082/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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