Nutritional Intervention for Older Adults With Complete Dentures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversidad de La Frontera
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Nutritional Intervention
BehavioralThis 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Masticatory Performance
Measurement of food fractionation capacity. Participants will chew a standardized food (peanuts) for 20 cycles; the particles will be dried and processed through a sieving system (sieves from 4.0 mm to 870 μm) to determine the percentage of fractionation.
Time frame
T0 (month 0), T1 (month 3) and T2 (month 6).2
Diet Quality Assessment
Diet quality will be assessed using the Chilean Healthy Eating Index (Índice de Dieta Mediterránea for Chile, IDM-Chile), which allows the evaluation of adherence to healthy dietary patterns in the study population.
Time frame
T0 (month 0), T1 (month 3) and T2 (month 6).3
Perceptions of Edentulism and Adaptation to Complete Removable Dentures
A qualitative assessment using a Grounded Theory framework conducted through semi-structured individual interviews to explore older adults' perceptions regarding their experiences with tooth loss, rehabilitation with complete removable dental prostheses, and their natural functional and social adaptation strategies in daily life. Interviews (30-60 minutes) will be audio-recorded, transcribed verbatim, and analyzed concurrently using ATLAS.ti software through progressive coding (open, axial, and selective) to develop a substantive explanatory model.
Time frame
Between month 0 and month 1 (collected during the initial phase of the study to capture prior experiences and avoid intervention bias).Secondary outcomes
1
Masticatory Kinematics: Number of Chewing Cycles
The total number of chewing cycles recorded during the mastication of a standardized food (peanuts), quantified using a 3D electromagnetic articulograph (AG501).
Time frame
T0 (month 0), T1 (month 3) and T2 (month 6).2
Masticatory Kinematics: Chewing Cycle Area
Assessment of chewing cycles focusing on the area, measured in square millimeters (mm²) using a 3D electromagnetic articulograph (AG501).
Time frame
T0 (month 0), T1 (month 3) and T2 (month 6).3
Masticatory Kinematics: Masticatory Frequency
Assessment of the masticatory frequency during mastication, measured as the number of cycles per second (cycles/s) using a 3D electromagnetic articulograph (AG501).
Time frame
T0 (month 0), T1 (month 3) and T2 (month 6).4
Masticatory Kinematics: Masticatory Speed
Assessment of chewing focusing on the movement velocity, measured in millimeters per second (mm/s) using a 3D electromagnetic articulograph (AG501).
Time frame
T0 (month 0), T1 (month 3) and T2 (month 6).Sponsors and contacts
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Universidad de La Frontera
Lead sponsor
Agencia Nacional de Investigación y Desarrollo
Collaborator
Source ClinicalTrials.gov