NCT05917548

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2023

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

June 6, 2023

Last Update Submit

January 2, 2024

Conditions

Keywords

TeledentistryOral health promotionElderly

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Acceptability: Utility of the teledentistry intervention

    2 days after sending each video

  • Acceptability: Dropout rate

    Change from baseline up to 6 weeks

  • Acceptability: Recomendation

    After 6 weeks

Study Arms (2)

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.

Device: Teledentistry oral health promotionBehavioral: 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.

Behavioral: Face-to-Face oral health promotion

Interventions

Educational videos specially designed and validated for elderly (duration 4 to 6 minutes each one)

Tele-education

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

ComparisonTele-education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with cognitive impairment (Folstein Mini-Mental ≤ 24)
  • Totally edentulous
  • Those who do not use WhatsApp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Dental Móvil TEGO-UFRO

Temuco, La Araucanía, Chile

Location

Related 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.

    PMID: 36833696BACKGROUND
  • 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.

    PMID: 35330690BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The random assignment was blinded for the dental care provider, outcome assesor and for the co-investigator in charge of the statistical analysis. (Double-blind RCT)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 26, 2023

Study Start

March 3, 2023

Primary Completion

August 30, 2023

Study Completion

October 14, 2023

Last Updated

January 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

All IPD underlying the results will be shared in one publication

Shared Documents
STUDY PROTOCOL
Time Frame
When summary data are published

Locations