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

Evaluation of the Impact on General Functionality of the Application of a Protocol of Immediate Prosthetic Functionalization in Patients With Deficient Removable Prostheses, Compared With the Conventional Treatment That is Delivery at the Secondary Level of the Health System to People Over 70 Years

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Elderly; Functional Status; Dental Restoration; Removable Dental Prosthesis
• Intervention / Treatment: Procedure: prosthetic refunctioning; Procedure: conventional prosthetic treatment

Detailed Description

In the public health system, older adults who need new dental prostheses are referred from primary health care to the rehabilitation specialty at the secondary care level. In many cases, they wear old, fractured, non-functional prosthetic devices and enter waiting lists for several months at the hospital level. During that time, they continue a process of oral hypofunction, a stage that gradually progresses to a process of oral dysfunction and decreased systemic function. Once they are called from the secondary level to enter treatment, they must wait for the rehabilitation process time that takes about two months, a period in which they continue with oral hypofunction, a functional pathophysiological condition that closely maintains the negatively impact in nutrition. Our proposal consists of carrying out a dental intervention, competence of the general dentist, when the patient begins the conventional treatment process, once you enter secondary care. This intervention is intended to immediately recover bilateral, homogeneous and simultaneous occlusal contacts, in addition to recovering the prosthetic biomechanical characteristics, by improving prosthetic support, retention and stability. All of this will be made with supplies commonly used in the dental clinic in health services and university teaching clinics. To evaluate the effect that this intervention will have at the muscular level, the patient's manual grip strength and gait speed will be measured, before the intervention and fifteen days later. Subsequently, once the new prostheses have been made, a new measurement will be made. A quality of life survey related to oral health will be applied to both groups, before and after the intervention and treatment. Based on international scientific evidence and on an investigation carried out by this research team (presented at the Chilean National Congress of Geriatrics and Gerontology), between October 2018 and April 2019 in 60 octogenarian older adults not wearing prostheses in whom dental prostheses were built - whose objective was to determine if there was an association between the use of prostheses that return the premolars and molars and the gripping force of the hand. Hand tightening force was measured before and 15 days after prosthetic rehabilitation with a manual hydraulic dynamometer (Jamar MR). For the cohort in study the use of prostheses increased the gripping force of the hand by a statistically significant value. This research aims to be a contribution for the Chilean population and for geriatrics, since the immediate recovery of oral functionality will eliminate a risk factor in older people, reducing conditions that increase frailty, which in cases of entering long-term lists is expected to have a greater impact at the systemic level and higher health costs. In some cases, out-of-pocket spending on dental supplies will also be reduced, because by recovering prosthetic biomechanical conditions, older people will not have to invest resources in creams and/or adhesive powders to "improve" prosthetic adhesion. With this, it would also be possible to contribute to the improvement of the quality of life of these patients as a result of the recovery of functions: masticatory and social. It will also allow a better integration of dentists into the multidisciplinary team in the care model proposed by the Health Ministry and will allow the development and implementation of a care protocol in primary health care, considering that the intervention will contemplate actions that are the responsibility of general dentists.

Without the development of this research, care system will maintain its long waits for this age group for treatment, a situation that will continue to increase considering that global projections related with a greater increase in older inhabitants, and also of the costs already described.

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Hospital Salvador

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 70 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Functionalization; 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; Active treatment followed by regular interventions
Active Comparator: control; conventional prosthetic treatment (new prosthesis)	Procedure: conventional prosthetic treatment; new prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gerardo F Fasce Pineda, MD

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SA20I0052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No