Nutritional Support for Older Adults with Complete Dentures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates a multidimensional nutritional intervention in adults aged 60–80 who wear complete dentures. It uses a convergent parallel mixed-methods design to combine quantitative assessments (chewing function, bite force, muscle thickness, salivary biomarkers, nutrition status, and cognitive performance) with qualitative insights. Participants are randomized to receive the nutritional intervention or usual care for a defined period, with assessments at baseline and follow-up. Key outcomes include masticatory performance, muscle health, saliva markers of stress and metabolism, nutritional status, quality of life, and cerebral blood flow. The study aims to illuminate how targeted nutrition may support function and well-being in edentulous older adults.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universidad de La Frontera
  Temuco, Cautín, Chile Recruiting

Study contacts

• Principal investigator: Ramón Fuentes, PhD — Universidad de La Frontera
• Study coordinator: Ramón Fuentes, PhD
• Email: ramon.fuentes@ufrontera.cl
• Phone: +56953339044

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.