Immediate Dental Prosthesis Functionalization Protocol in People Over 70 Years of Age

NCT05818436 | Completed

• 1 other identifier: 05595304
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Prosthesis Failure; Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (3)

• Handgrip strength change

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

  Time Frame: Baseline, 15 and 30 days after intervention

• 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

• 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

Study Arms (2)

Experimental: Oral Functionalization Prosthesis repairment

EXPERIMENTAL

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: Procedure: prosthetic functioning; Device: Conventional dental prosthesis

Active Comparator: control

ACTIVE COMPARATOR

Active Comparator: control conventional prosthetic treatment (new prosthesis)

Device: Conventional dental prosthesis

Interventions

Procedure: prosthetic functioning PROCEDURE

Prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts

Experimental: Oral Functionalization Prosthesis repairment

Conventional dental prosthesis DEVICE

: conventional prosthetic treatment new prosthesis

Active Comparator: control; Experimental: Oral Functionalization Prosthesis repairment

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

• University of Chile: lead
• National Fund for Research and Development in Health, Chile: collaborator

Study Sites (1)

Hospital Salvador

Santiago, Santiago Metropolitan, 7500000, Chile

Location

Study Officials

• Pilar O Barahona, DDS, MSC

  University of Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 18, 2023
• Study Start: April 19, 2021
• Primary Completion: October 30, 2023
• Study Completion: March 30, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CL (1)