Immediate Dental Prosthesis Functionalization Protocol in People Over 70 Years of Age
NCT05818436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2025-03-30
Summary
Sarcopenia and malnutrition are closely involved in frailty. To prevent them, it is essential to assess oral function. "Oral fragility" manifests with specific signs or symptoms, including occlusion loss due to tooth loss and chewing difficulty. To recover from it, restoring function by placing a dental prosthesis in the event of tooth loss is essential. In Chile, many patients referred to secondary care to perform new prosthetic treatment live in conditions of less oral functionality and enter waiting lists that can take years, impacting general functionality. Falls are a public health problem with a high economic cost, the second cause of death worldwide. One of the causes is sarcopenia, and it has been studied that the decrease in the number of teeth and the occlusal posterior support region may be risk factors for decreased gait speed, an objective measurement of fall risk. It has been studied that the decrease in the number of teeth causes a reduction in total muscle mass, walking speed and lower quality of life.
General objective: To evaluate the impact on the general functionality of applying an immediate prosthetic functionalization protocol in patients with deficient removable prostheses, compared with conventional treatment, at the secondary level of the health system, in patients over 70 years of age.
Methodology: randomized, double-blind clinical trial with two groups of 62 patients each: experimental and control. The intervention will consist of recovering prosthetic function in one session before conventional rehabilitation vs the control group receiving conventional rehabilitation. Measurements will include manual grip strength measurements made with a Jamar dynamometer, timed up-and-go test, before and after prosthetic treatments and quality of life related to oral health through Ohip 7sp. Descriptive statistics will be applied through the registration of frequency and contingency tables. To compare hand grip strength, Pearson's Correlation will be used; for risk of pre and post-fall, the t-test will be applied for two related samples; for quality of life before and after the intervention, Chi2 will be used; changes in grip strength, fall risk and quality of life, between the different groups according to the Eichner index, one-way ANOVA will be applied, for related samples.
Conditions
- Dental Prosthesis Failure
- Frail Elderly Syndrome
Interventions
- PROCEDURE
-
Procedure: prosthetic functioning
Prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts
- DEVICE
-
Conventional dental prosthesis
: conventional prosthetic treatment new prosthesis
Sponsors & Collaborators
-
National Fund for Research and Development in Health, Chile
collaborator OTHER -
University of Chile
lead OTHER
Principal Investigators
-
Pilar O Barahona, DDS, MSC · University of Chile
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-19
- Primary Completion
- 2023-10-30
- Completion
- 2024-03-30
Countries
- Chile
Study Locations
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