Trial · NCT07890753
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Salivary DNA Methylation Age Acceleration | Baseline, 3 months, 12 months, and 24 months | Biological age acceleration will be assessed as the difference between DNA methylation-derived biological age estimated from saliva samples and chronological age, expressed in years. Changes from baseline will be evaluated longitudinally and compared between the implant rehabilitation cohort and the delayed-treatment comparison cohort. |
| Secondary | Change in Facial Biological Age Acceleration | Baseline, 3 months, 12 months, and 24 months | Facial biological age will be estimated from standardized facial photographs using an artificial intelligence-based age estimation method. The difference between estimated facial biological age and chronological age, expressed in years, will be assessed longitudinally. |
| Secondary | Change in Handgrip Strength | Baseline, 3 months, 12 months, and 24 months | Handgrip strength will be measured using a standardized grip strength assessment. Longitudinal changes in handgrip strength will be evaluated. |
| Secondary | Change in Gait Speed | Baseline, 3 months, 12 months, and 24 months | Gait speed will be assessed using a standardized walking assessment to evaluate longitudinal changes in physical performance. |
| Secondary | Change in Physical Frailty | Baseline, 3 months, 12 months, and 24 months | Physical frailty will be assessed using the Fried Frailty Phenotype, which evaluates five components: unintentional weight loss, self-reported exhaustion, low physical activity, slow walking speed, and weak grip strength. Each component is scored as 0 (criterion absent) or 1 (criterion present), yielding a total score ranging from 0 to 5. Higher scores indicate greater frailty. Scores of 0 indicate robustness, scores of 1-2 indicate prefrailty, and scores of 3-5 indicate frailty. Changes in total frailty scores and frailty categories will be evaluated longitudinally. |
| Secondary | Change in Oral Health-Related Quality of Life | Baseline, 3 months, 12 months, and 24 months | Oral health-related quality of life will be assessed using the 14-item Oral Health Impact Profile (OHIP-14). Each item is scored from 0 (never) to 4 (very often), yielding a total score ranging from 0 to 56. Higher scores indicate greater negative impacts of oral health on quality of life and therefore worse oral health-related quality of life. Changes in total OHIP-14 scores from baseline will be evaluated longitudinally. |
| Secondary | Change in Nutritional Status | Baseline, 3 months, 12 months, and 24 months | Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF), which has a total score ranging from 0 to 14. Higher scores indicate better nutritional status. Scores of 0-7 indicate malnutrition, 8-11 indicate risk of malnutrition, and 12-14 indicate normal nutritional status. Changes in total scores from baseline will be evaluated longitudinally. |
| Secondary | Change in Anxiety Symptoms Assessed by the Beck Anxiety Inventory (BAI) | Baseline, 3 months, 12 months, and 24 months | Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. Changes in total BAI scores from baseline will be evaluated longitudinally. |
| Secondary | Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI) | Baseline, 3 months, 12 months, and 24 months | Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. Changes in total BDI scores from baseline will be evaluated longitudinally. |
| Secondary | Change in Global Cognitive Function | Baseline, 3 months, 12 months, and 24 months | Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), with total scores ranging from 0 to 30. Higher scores indicate better global cognitive performance. Changes in total MoCA scores from baseline will be evaluated longitudinally. |
| Secondary | Change in Information Processing Speed | Baseline, 3 months, 12 months, and 24 months | Information processing speed will be assessed using the Digit Symbol Substitution Test (DSST). Performance will be measured by the number of correctly completed symbol-digit substitutions within the specified time limit. Higher scores indicate better information processing speed. Changes in DSST scores from baseline will be evaluated longitudinally. |
| Secondary | Change in Fine Motor Function | Baseline, 3 months, 12 months, and 24 months | Fine motor function will be assessed using a standardized Pegboard Test. Changes in test performance will be evaluated longitudinally. |
| Secondary | Change in Resting-State EEG Measures | Baseline, 3 months, 12 months, and 24 months | Resting-state electroencephalography (EEG) will be used to assess changes in spontaneous brain activity and functional connectivity over time. |
| Secondary | Change in Brain Structure and Functional Connectivity | Baseline, 3 months, 12 months, and 24 months | Magnetic resonance imaging (MRI), including structural T1-weighted imaging, T2-FLAIR, diffusion tensor imaging, and resting-state functional MRI, will be used to evaluate longitudinal changes in brain structure, white matter characteristics, and functional connectivity. |
| Secondary | Change in Cortical Hemodynamic Responses During Chewing | Baseline, 3 months, 12 months, and 24 months | Functional near-infrared spectroscopy (fNIRS) will be performed during standardized chewing tasks under soft and hard chewing conditions to assess changes in cortical hemodynamic responses in sensorimotor and prefrontal regions. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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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