Clinical Trials Logo

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


Recruitment information / eligibility

Status Recruiting
Enrollment 118
Est. completion date June 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Design


Intervention

Procedure:
Procedure: prosthetic functioning
Prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts
Device:
Conventional dental prosthesis
: conventional prosthetic treatment new prosthesis

Locations

Country Name City State
Chile Hospital Salvador Santiago

Sponsors (2)

Lead Sponsor Collaborator
University of Chile National Fund for Research and Development in Health, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Handgrip strength change measurment in kilograms of handgrip strength. Higher scores mean a better outcome Time Frame: Baseline, 15 and 30 days after intervention
Primary Time up-and-go change Measurement of Timed up-and-go test. Measured in seconds. Higher scores mean worse outcomes Time Frame: Baseline, 15 and 30 days after intervention
Primary Estimation of oral health-related Quality of Life change Use of Oral Health Impact Profile Ultra Short Version (OHIP 7Tsp) survey. Score from 0 to 28, higher scores mean worse outcomes Time Frame: Baseline, 15 and 30 days after intervention
See also
  Status Clinical Trial Phase
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Completed NCT03271112 - Frailty Prevention in Elders From Reunion Island N/A
Recruiting NCT03141866 - Seated Physical Activity in Ageing N/A
Completed NCT03180606 - Enhanced Primary Care for Elderly
Recruiting NCT05940779 - Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial. N/A
Active, not recruiting NCT05961319 - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
Recruiting NCT04518423 - Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
Completed NCT03883425 - Frailty and Complexity Among Home Service Recipients
Recruiting NCT03657940 - Impact of a Multicomponent Exercise Program on Functional Capacity in Frail Aged Participants With Cognitive Decline N/A
Withdrawn NCT03176030 - Fortified Foods in Older Inpatients
Completed NCT03724461 - Effects of Resistance Training With High vs. Light-moderate Loads on Muscle-tendon Function in the Elderly N/A
Completed NCT04615533 - Validity Reliability of FrailBESTest in Older Adults
Recruiting NCT04238494 - Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study N/A
Active, not recruiting NCT06079762 - AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program N/A
Not yet recruiting NCT06019390 - eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study N/A
Recruiting NCT03534765 - Frailty and Sarcopenia Outcomes in Emergency General Surgery
Active, not recruiting NCT03721471 - Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
Completed NCT03689322 - Effects of WBV Associated With IMT on Inflammatory Markers, Body Composition, Muscle Strength and Thickness N/A
Completed NCT03688932 - Effects of WBV Associated With IMT on Functionality N/A
Recruiting NCT03068299 - Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities N/A