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Nutritional Intervention for Older Adults With Complete Dentures

Sponsor: Universidad de La Frontera • ClinicalTrials.gov ID: NCT07692828

Registry updated: 2026-09-17

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Description

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.

Interventions

Nutritional Intervention (Behavioral)
This 6-month nutritional intervention for older adults wearing complete removable dentures consists of 6 components: 1. In-person nutritional consultation: A trained nutritionist will provide dietary guidance, adapt recommendations to individual needs and support the initiation of dietary changes. 2. Telephone follow-up: Monthly counseling sessions to monitor progress, address question and reinforce adherence to the intervention. 3. Dietary guidelines booklet: Includes specific nutritional recommendations, weekly menu proposals, healthy recipes and guidance for incorporating foods with different textures and hardness levels, with the aim of stimulating masticatory function according to individual tolerance. 4. Cooking workshop: Will teach participants how to prepare the recipes included in the dietary guidelines booklet. 5. Food box delivery: Monthly supply of non-perishable ingredients. 6. Mobile app: Digital tool providing the digital guide, educational videos and push notifications.

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.

Conditions

Edentulism Complete Denture, Complete Mastication Disorder

Locations

Universidad de La Frontera — Temuco, Cautín, Chile

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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