Impact on General Functionality of an Immediate Prosthetic Functionalization Protocol in People Over 70 Years of Age With Deficient Removable Prostheses
NCT05595304 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2022-10-26
Summary
Title: Evaluation of the impact on general functionality of the application of an immediate prosthetic functionalization protocol, in patients with deficient removable prostheses, compared with the conventional treatment that is delivered at the secondary level of the health system, to people over 70 years of age.
Introduction: Sarcopenia and malnutrition are closely involved in frailty. To prevent them it is important to assess oral function. "Oral fragility" manifests with specific signs or symptoms, among which are loss of occlusion due to tooth loss and chewing difficulty. To recover from it, it is important to restore function by placing a dental prosthesis in the event of tooth loss. In Chile, a large percentage of patients who are referred to secondary care to perform new prosthetic treatment, lives in conditions of less oral functionality and enters waiting lists that can take years, with a silent impact on general functionality. Falls are a public health problem with a significant economic cost, being 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.
Hypothesis: The recovery of immediate functionality in deficient prostheses in patients 70 years of age and older will have a positive and rapid impact on general functionality and on their assessment of oral health related quality of life.
General objective: To evaluate the impact on general functionality of the application of 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 that will receive 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, the Pearson's Correlation will be used; for risk of pre and post fall, the t-test will be applied for 2 related samples; for quality of life before and after 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.
Results: A short-term improvement is expected in patients whose functionality will be recovered, which, being a simple technique of competence of the general dentist, could be applied in primary care, without loss of valuable time before attention is achieved, at the secondary level for rehabilitation with new prostheses.
Conditions
- Removable Dental Prosthesis
- Dental Restoration
- Elderly
- Functional Status
Interventions
- PROCEDURE
-
prosthetic refunctioning
Active treatment followed by regular interventions
- PROCEDURE
-
conventional prosthetic treatment
new prosthesis
Sponsors & Collaborators
-
Gerardo F Fasce Pineda, MD
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-03
- Primary Completion
- 2022-12-30
- Completion
- 2023-05-30
Countries
- Chile
Study Locations
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