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Not Yet Recruiting NCT07692828

Nutritional Intervention for Older Adults With Complete Dentures

Conditions: Edentulism Complete, Denture, Complete, Mastication Disorder

Sex: All
Ages: 60 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Universidad de La Frontera

Location: Universidad de La Frontera Temuco Cautín

Summary

The purpose of this clinical trial is to test a nutritional intervention. This study helps older adults who wear complete removable dentures improve their health. The main questions the study aims to answer are: * What are the participants life experiences living with complete dentures before the intervention? * Does the intervention improve the diet quality of the participants? * Does the intervention improve nutritional status of the participants? * Does the intervention improve chewing performance and muscle strength? * Does the intervention increase the thickness of the masticatory muscles? * Does the intervention improve stress and muscle health markers in saliva? * Does the intervention improve cognitive performance and oral health-related quality of life? * Does the intervention improve cerebral blood flow? The study will include a total of 40 participants, who will be assigned to two groups. One group of 20 participants will receive the nutritional intervention, while the other group of 20 participants will maintain their usual diet during the study period. This comparison will allow the investigators to assess the effectiveness of the intervention. Participants will: * Take part in a personal interview about their life experience with dentures. * Follow a dietary guide with recommendations on specific food textures for six months. * Receive personalized nutritional counseling and participate in healthy cooking workshops. * Use a custom-built mobile application to access the educational content of the nutritional guide, view instructional videos uploaded biweekly, and receive automated reminder notifications. * Attend clinical follow-up assessments, including chewing performance, muscle assessment, saliva markers, assessment of diet quality and nutritional status, cognitive tests, and oral health-related quality of life. * Complete these assessments at three main time points: baseline, 3 months, and 6 months.

Eligibility Criteria

Inclusion Criteria: * Men and women aged 60 to 80 years. * Systemically healthy individuals or those with controlled chronic systemic conditions under regular medical supervision. * Functionally independent individuals, or those with a dedicated family member or caregiver available to provide support throughout the study period. * Wearers of both maxillary and mandibular complete removable dentures. * Adequate stability, retention, and functionality of both complete dentures allowing the participant to chew effectively during daily meals (accepting minor retention or stability limitations in the mandibular prosthesis, provided routine functional mastication is maintained). * Acceptable centric occlusion and jaw relationship allowing functional mastication. * Intact oral mucosa without active lesions or severe soreness in the denture-bearing areas. Exclusion Criteria: * Altered salivary flow (hyposalivation or xerostomia) identified via anamnesis and sialometry, with an unstimulated salivary flow rate \< 0.1 mL/min or a stimulated salivary flow rate \< 0.5 mL/min. * Active oral mucosa diseases or lesions (e.g., cheilitis, denture stomatitis, ulcers, or aphthae) verified through intraoral examination. * Diagnosis of a major neurocognitive disorder by a qualified professional, verified via medical records and/or caregiver interview. * Color blindness (daltonism or color vision deficiency). * Presence of signs or symptoms of temporomandibular disorders (TMD). * Known history of allergy to peanuts or latex. * Underweight or severe undernutrition, defined as a Body Mass Index (BMI) \< 18.5 kg/m².

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07692828). StuddyBuddy aggregates publicly available trial information.