Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05818436 |
| Other study ID # |
05595304 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 19, 2021 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University of Chile |
| Contact |
Gerardo Fasce, DDS, MSC |
| Phone |
+56998256400 |
| Email |
gfasce[@]hcuch.cl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
In the public health system, older adults who need new dental prostheses are referred from
primary health care to the rehabilitation speciality 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, which 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, which takes about two months, a period in which
they continue with oral hypofunction. This functional pathophysiological condition closely
maintains the negative impact on nutrition. Our proposal consists of carrying out a dental
intervention, the 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 and recover the
prosthetic biomechanical characteristics by improving prosthetic support, retention and
stability. This will be made with supplies commonly used in the dental clinic, health
services and university teaching clinics. To evaluate this intervention's effect 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. 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 the study, the use of prostheses
increased the hand's gripping force by a statistically significant value.
This research aims to contribute to the Chilean population since the immediate recovery of
oral functionality may contribute to reducing conditions that increase frailty, which in
cases of entering long-term lists is expected to have a more significant impact on 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 adhesive powders to "improve" prosthetic adhesion. With this, it is
also possible to contribute to improving the quality of life of these patients due to the
recovery of functions: masticatory and social. It will also allow better integration of
dentists into the multidisciplinary team in the care model proposed by the Health Ministry.
It 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, the 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 to a greater increase in older inhabitants and also the costs
already described
