Trial · NCT07692828
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Masticatory Performance | T0 (month 0), T1 (month 3) and T2 (month 6). | 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. |
| Primary | Diet Quality Assessment | T0 (month 0), T1 (month 3) and T2 (month 6). | 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. |
| Primary | Perceptions of Edentulism and Adaptation to Complete Removable Dentures | Between month 0 and month 1 (collected during the initial phase of the study to capture prior experiences and avoid intervention bias). | 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. |
| Secondary | Masticatory Kinematics: Number of Chewing Cycles | T0 (month 0), T1 (month 3) and T2 (month 6). | The total number of chewing cycles recorded during the mastication of a standardized food (peanuts), quantified using a 3D electromagnetic articulograph (AG501). |
| Secondary | Masticatory Kinematics: Chewing Cycle Area | T0 (month 0), T1 (month 3) and T2 (month 6). | Assessment of chewing cycles focusing on the area, measured in square millimeters (mm²) using a 3D electromagnetic articulograph (AG501). |
| Secondary | Masticatory Kinematics: Masticatory Frequency | T0 (month 0), T1 (month 3) and T2 (month 6). | Assessment of the masticatory frequency during mastication, measured as the number of cycles per second (cycles/s) using a 3D electromagnetic articulograph (AG501). |
| Secondary | Masticatory Kinematics: Masticatory Speed | T0 (month 0), T1 (month 3) and T2 (month 6). | Assessment of chewing focusing on the movement velocity, measured in millimeters per second (mm/s) using a 3D electromagnetic articulograph (AG501). |
| Secondary | Maximum Bite Force | T0 (month 0), T1 (month 3) and T2 (month 6). | Measurement of maximum voluntary contraction in Newtons (N) using a digital gnathodynamometer placed between the first prosthetic molars. |
| Secondary | Masticatory Muscles Thickness | T0 (month 0) and T2 (month 6). | Evaluation of the thickness of the masseter and anterior temporalis muscles, measured in millimeters (mm) using a portable ultrasound device with a linear transducer. |
| Secondary | Salivary Biomarkers: Cortisol | T0 (month 0) and T2 (month 6). | 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). |
| Secondary | Salivary Biomarkers: Insulin-like Growth Factor 1 (IGF-1) | T0 (month 0) and T2 (month 6). | 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). |
| Secondary | Salivary Biomarkers: Creatine Kinase (CK) | T0 (month 0) and T2 (month 6). | 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). |
| Secondary | Salivary Biomarkers: General Oxidative Stress (ROS) | T0 (month 0) and T2 (month 6). | 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. |
| Secondary | Salivary Biomarkers: Total Antioxidant Capacity (TAC) | T0 (month 0) and T2 (month 6). | 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. |
| Secondary | Oral Health-Related Quality of Life | T0 (month 0), T1 (month 3) and T2 (month 6). | 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. |
| Secondary | Cognitive Performance: Addenbrooke's Cognitive Examination (ACE) | T0 (month 0), T1 (month 3) and T2 (Month 6). | 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. |
| Secondary | Cognitive Performance: Stroop Test | T0 (month 0), T1 (month 3) and T2 (month 6). | 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. |
| Secondary | Cerebral Blood Flow: Mean Flow Velocity | T0 (month 0) and T2 (month 6). | 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). |
| Secondary | Cerebral Blood Flow: Pulsatility Index | T0 (month 0) and T2 (month 6). | 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). |
| Secondary | Nutritional Status: Body Mass Index (BMI) | T0 (month 0), T1 (month 3) and T2 (month 6). | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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