Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05595304 |
| Other study ID # |
SA20I0052 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 3, 2020 |
| Est. completion date |
May 30, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Comisión Nacional de Investigación Científica y Tecnológica |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
