Impact of an immediate dental prosthetic functionalization protocol on the general functionality of patients with deficient removable dental prostheses: a randomized clinical trial protocol

Abstract

The ageing population has increased globally, leading to the prevalence of geriatric syndromes, including frailty. Frailty is associated with multiple physiological system impairments, increased vulnerability to stressors, and functional disabilities. Dental problems are common among older adults and can contribute to frailty by causing chewing difficulties and malnutrition. The objective of this randomized clinical trial is to evaluate the impact of an immediate prosthetic functionalization protocol on the general functionality of patients with deficient removable prostheses in the Chilean public health system. This study protocol follows the Standard Protocol Items for Reporting in Trials (SPIRIT) guidelines. Patients aged 70 years or older, referred for prosthetic rehabilitation treatment, will be enrolled from the Eastern Metropolitan Health Service of Chile. The sample size calculation determined a sample universe of 120 individuals. The participants will be randomized into two groups: the control group will receive conventional prosthetic treatment, while the experimental group will undergo immediate prosthetic functionalization prior to conventional treatment. Various measurements will be assessed at baseline, 15 days after baseline, and at patient discharge, including hand grip strength, Timed Up and Go test, and quality of life related to oral health. Statistical analysis will be performed to compare the outcomes between the two groups, considering age, gender, and comorbidities. The findings from this trial will provide insights into the impact of immediate prosthetic functionalization on general functionality in patients with deficient removable prostheses. The results will contribute to improving the oral health and overall well-being of older adults, particularly those in the Chilean public health system. This study has received ethical approval and is registered in the U.S. National Library of Medicine Clinical Trials database (ClinicalTrials.gov Identifier: NCT05818436).