Impact on General Functionality of an Immediate Prosthetic Functionalization Protocol in People Over 70 Years of Age With Deficient Removable Prostheses

NCT05595304 | Unknown Phase 3 DMC

• 1 other identifier: SA20I0052
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Handgrip strength

  measurment in kilograms of handgrip strength. Higher scores mean a better outcome

  15-30 days

• Falls Risk

  Measurement of Time up and go test. Measured in seconds. Higher scores mean worse outcomes

  15-30 days

• Estimation of Quality of Life

  Use of Oral Health Impact Profile Ultra Short Version (OHIP 7Tsp) survey. Score from 0 to 28, higher scores mean worse outcomes

  15-30 days

Study Arms (2)

Oral Functionalization

EXPERIMENTAL

Prosthesis repairment: prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts and follow up with conventional prosthesis treatment

Procedure: prosthetic refunctioning

control

ACTIVE COMPARATOR

conventional prosthetic treatment (new prosthesis)

Procedure: conventional prosthetic treatment

Interventions

prosthetic refunctioning PROCEDURE

Active treatment followed by regular interventions

Oral Functionalization

conventional prosthetic treatment PROCEDURE

new prosthesis

control

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• or older
• Willingness to participate
• Discharged from Primary Care to the Oral Health Department at Hospital Salvador, Santiago Chile for prosthetic treatment
• With both maxilar an mandibular prosthesis affected
• Eichner groups B3, B4, C1, C2 and C3.

You may not qualify if:

• Cognitive impairment (Pfeiffer test classified as moderate or severe)
• Diseases that affect the ability to use facial muscles
• Soft Tissue diseases that affect facial functionality like fibroids

Sponsors & Collaborators

• Gerardo F Fasce Pineda, MD: lead

Study Sites (1)

Hospital Salvador

Santiago, Chile

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Geriatrics - Hospital Clinico Universidad de Chile

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 26, 2022
• Study Start: November 3, 2020
• Primary Completion: December 30, 2022
• Study Completion: May 30, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

CL (1)