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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05917548
Other study ID # 082/22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2023
Est. completion date October 14, 2023

Study information

Verified date January 2024
Source Universidad de La Frontera
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date October 14, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Teledentistry oral health promotion
Educational videos specially designed and validated for elderly (duration 4 to 6 minutes each one)
Behavioral:
Face-to-Face oral health promotion
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

Locations

Country Name City State
Chile Clinica Dental Móvil TEGO-UFRO Temuco La Araucanía

Sponsors (4)

Lead Sponsor Collaborator
Fernanda Muñoz Sepúlveda Beca de Postgrado Magíster Nacional, ANID, Centro Interuniversitario de Envejecimiento Saludable (CIES), Subvención Presidencial, Ministerio de Hacienda, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline oral health knowledges at 6 weeks
Primary 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 Change from baseline oral health attitudes at 6 weeks
Primary 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. Change from baseline oral health self-efficacy at 6 weeks
Secondary Acceptability: Utility of the teledentistry intervention The utility of each video was assesed via a 4-point scale 2 days after sending each video
Secondary Acceptability: Dropout rate Percentage withdrawal of study participants Change from baseline up to 6 weeks
Secondary 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 After 6 weeks
See also
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