An interventional study of Nutritional Intervention in Edentulism Complete, Denture, Complete and Mastication Disorder, sponsored by Universidad de La Frontera. Recruiting at 1 site in Chile. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Universidad de La Frontera · Not applicable, Interventional, and Treatment
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:
Participants will:
This clinical trial evaluates the effectiveness of a multidimensional nutritional intervention on the functional, physiological, and cognitive health of older adults wearing complete removable dentures. The study employs a convergent parallel mixed-methods design to integrate quantitative with qualitative outcomes.
Methodological Evaluation Protocols
Participants will undergo comprehensive clinical and laboratory assessments:
The 40 participants will be randomly allocated into two balanced groups (20 participants per arm):
Exclusion Criteria:
Participants assigned to the Intervention Group will receive a 6-month educational and nutritional intervention designed for older adults who wear complete removable dentures. The intervention includes in-person nutritional consultation, telephone follow-up nutritional counseling, a dietary guideline booklet adapted for denture wearers, a practical healthy cooking workshop, and monthly food box delivery to support adherence. Additionally, the intervention will be supported by a custom-developed mobile application. Through this digital tool, participants can access the digital version of the dietary guide, view educational and instructional videos uploaded biweekly throughout the 6-month period.
Behavioral: Nutritional Intervention
Participants assigned to the Control Group will maintain their usual diet during the 6-month study period and will undergo the same follow-up assessments as the Intervention Group. To ensure ethical equity, upon study completion, participants in the Control Group will receive full access to the mobile application, a food box, and the dietary guide booklet, and they will be invited to attend a practical healthy cooking workshop led by a nutritionist and a chef.
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.
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).
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).
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).
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).
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).
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).
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).
Maximum Bite Force
Measurement of maximum voluntary contraction in Newtons (N) using a digital gnathodynamometer placed between the first prosthetic molars.
Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).
Masticatory Muscles Thickness
Evaluation of the thickness of the masseter and anterior temporalis muscles, measured in millimeters (mm) using a portable ultrasound device with a linear transducer.
Time frame: T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Cortisol
Laboratory analysis of saliva samples to quantify cortisol concentration, a biomarker of physiological stress, samples will be analyzed using a Synergy HT Multimodal Reader (Biotek, USA). The outcome will be determined via enzyme-linked immunosorbent assay (ELISA) and expressed in nanograms per milliliter (ng/mL).
Time frame: T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Insulin-like Growth Factor 1 (IGF-1)
Laboratory analysis of saliva samples to quantify Insulin-like Growth Factor 1 (IGF-1) concentration, a biomarker related to muscle health and growth, samples will be analyzed using a Synergy HT Multimodal Reader (Biotek, USA). The outcome will be determined via immunoassay and expressed in picograms per milliliter (pg/mL).
Time frame: T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Creatine Kinase (CK)
Laboratory analysis of saliva samples to quantify Creatine Kinase (CK) enzymatic activity, a biomarker of muscle tissue stress and health, samples will be analyzed using a Synergy HT Multimodal Reader (Biotek, USA). The outcome will be determined via spectrophotometry and expressed in Units per liter (U/L).
Time frame: T0 (month 0) and T2 (month 6).
Salivary Biomarkers: General Oxidative Stress (ROS)
Laboratory analysis of saliva samples to quantify general oxidative stress by measuring reactive oxygen species (ROS) content. Saliva samples will be incubated with the CH2DCFDA fluorescent probe (30 uM) for 1 hour at 37°C in the dark. Fluorescence emission will be recorded at 530 nm using a Synergy HT multimodal reader (Biotek, USA), with H2O2 (100 uM) used as a positive control. The outcome will be reported as fluorescence intensity measured in Relative Fluorescence Units (RFU), where higher RFU values indicate a higher level of general oxidative stress.
Time frame: T0 (month 0) and T2 (month 6).
Salivary Biomarkers: Total Antioxidant Capacity (TAC)
Laboratory analysis of saliva samples to quantify total antioxidant capacity using the Oxygen Radical Absorbance Capacity (ORAC) method. The assay monitors the decay of fluorescein fluorescence (excitation/emission at 495/530 nm) over 120 minutes induced by AAPH free radicals, which is counteracted by the antioxidants in the sample. Readings will be captured every 2 minutes using a Synergy HT Multimodal Reader (Biotek, USA) and interpolated against a Trolox calibration curve. The outcome will be reported in millimoles of Trolox equivalents per milliliter of saliva (mmol TE/mL), where higher ORAC values indicate a greater total antioxidant capacity.
Time frame: T0 (month 0) and T2 (month 6).
Oral Health-Related Quality of Life
Evaluation of the impact of oral health on the patient's quality of life using the OHIP-7Sp questionnaire, validated for the elderly Chilean population. Total scores range from 0 to 28, where higher scores indicate poorer oral health-related quality of life.
Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).
Cognitive Performance: Addenbrooke's Cognitive Examination (ACE)
Evaluation of global cognitive status and its subdomains (orientation, attention, memory, language, and visuospatial skills) using the Chilean version of the Addenbrooke's Cognitive Examination (ACE). The outcome is measured using the instrument's total score, which ranges from 0 to 100 points, where higher scores indicate better global cognitive efficiency.
Time frame: T0 (month 0), T1 (month 3) and T2 (Month 6).
Cognitive Performance: Stroop Test
Evaluation of executive functions, including selective attention, cognitive flexibility, inhibition, and information processing speed, administered digitally via the "EncephalApp-Stroop Test" application on a tablet. The outcome is measured as the total completion time in seconds, where shorter execution times indicate better executive performance and cognitive control.
Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).
Cerebral Blood Flow: Mean Flow Velocity
Assessment of cerebral hemodynamics at rest focusing on the mean flow velocity of the anterior and middle cerebral arteries to evaluate neurovascular coupling. Measurements will be recorded in centimeters per second (cm/s) through Transcranial Doppler ultrasonography using a PMD-100 system (Spencer Technologies, Redmond, USA) with a 2 MHz transducer at a depth of 5 cm. The assessment will be conducted by a specialized neurologist at the neurology service of the Dr. Hernán Henríquez Aravena Hospital (Temuco, Chile).
Time frame: T0 (month 0) and T2 (month 6).
Cerebral Blood Flow: Pulsatility Index
Assessment of cerebral hemodynamics at rest focusing on the pulsatility of the anterior and middle cerebral arteries to evaluate neurovascular coupling and cerebrovascular resistance. The outcome will be calculated as a dimensionless ratio value through Transcranial Doppler ultrasonography using a PMD-100 system (Spencer Technologies, Redmond, USA) with a 2 MHz transducer at a depth of 5 cm. The assessment will be conducted by a specialized neurologist at the neurology service of the Dr. Hernán Henríquez Aravena Hospital (Temuco, Chile).
Time frame: T0 (month 0) and T2 (month 6).
Nutritional Status: Body Mass Index (BMI)
Anthropometric evaluation of nutritional status. Participants weight (measured in kilograms) and height (measured in meters) will be aggregated to calculate and report the Body Mass Index (BMI), expressed in kilograms per square meter (kg/m²).
Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).
Nutritional Status: Waist Circumference
Anthropometric assessment of abdominal fat distribution. Measurement of the participant's waist circumference, recorded in centimeters (cm) using a standardized non-elastic flexible tape measure.
Time frame: T0 (month 0), T1 (month 3), and T2 (month 6).
Body Composition: Body Fat Percentage
Evaluation of tissue body composition, specifically assessing the total body fat percentage (%), determined via bioelectrical impedance analysis (BIA).
Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).
Body Composition: Skeletal Muscle Mass Percentage
Evaluation of muscular health and body composition, specifically assessing the skeletal muscle mass percentage (%), determined via bioelectrical impedance analysis (BIA).
Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).
Plan to share: No — To protect participant privacy and maintain data confidentiality, individual participant data will not be shared publicly. Final study results will be disseminated through peer-reviewed publications and doctoral thesis presentations.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad de La Frontera