EdentulismNCT07890753
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
An observational study of Edentulism and Biological Aging, run by Junyu Shi at 1 site in China.
Trial summary
This study aims to investigate the association between full-arch implant-supported fixed dental rehabilitation and changes in biological aging among adults with complete tooth loss (edentulism). A total of 60 adults aged 50 years or older with complete tooth loss will be enrolled in this prospective cohort study. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Edentulism, Biological Aging
- What is being tested?
- Full-Arch Implant-Supported Fixed Dental Rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults aged 50 years or older with complete edentulism who seek care at the Department of Oral Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, China. Eligible participants will be enrolled into two prospective observational cohorts according to their independently chosen treatment timing: an implant rehabilitation cohort and a delayed-treatment comparison cohort. Approximately 30 participants will be recruited into each cohort, for a total of 60 participants. Treatment decisions and timing will be determined by patients and their treating clinicians as part of routine clinical care, without assignment by the investigators.
Who may be able to join
- Patients with complete edentulism.
- Adults aged 50 years or older, regardless of sex.
- Ability and willingness to complete the scheduled assessments at T0, T1, T2, and T3.
- Eligibility for one of the following observational cohorts:
- Implant rehabilitation cohort: Patients with complete edentulism who are clinically eligible for full-arch implant-supported fixed dental rehabilitation and plan to undergo treatment.
- Delayed-treatment comparison cohort: Patients with complete edentulism who voluntarily choose to delay full-arch implant-supported fixed dental rehabilitation for approximately three months.
Who cannot join
- Systemic diseases that may substantially affect bone metabolism or biological aging, such as severe diabetes mellitus or osteoporosis.
- Recent use of bisphosphonates.
- Severe neurological disorders, major psychiatric disorders, or serious systemic diseases that may substantially affect cognitive function, brain structure or function, or systemic aging biomarkers.
- Any other condition or circumstance that prevents completion of the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Junyu Shi
About this study
Official title: Association Between Full-Arch Implant-Supported Fixed Prosthetic Rehabilitation and Biological Aging in Edentulous Patients: A Prospective Cohort Study
This study aims to investigate the association between full-arch implant-supported fixed dental rehabilitation and changes in biological aging among adults with complete tooth loss (edentulism).
A total of 60 adults aged 50 years or older with complete tooth loss will be enrolled in this prospective cohort study. Participants will be included in one of two groups: an implant rehabilitation group (30 participants) receiving full-arch implant-supported fixed dental prostheses, and a delayed-treatment comparison group (30 participants) receiving the same treatment after a three-month delay.
Read more
The main outcome is the change in biological age estimated from DNA methylation in saliva samples, compared with chronological age. Other outcomes include facial biological age, physical frailty, quality of life, nutritional status, emotional well-being, cognitive function, and brain function.
Participants will undergo assessments at baseline and at 3, 12, and 24 months. These assessments will include saliva collection, facial photographs and scans, physical function tests, questionnaires, cognitive tests, and brain function measurements using electroencephalography (EEG), magnetic resonance imaging (MRI), and functional near-infrared spectroscopy (fNIRS).
The study will examine whether changes in oral function following implant-supported fixed dental rehabilitation are associated with changes in biological aging and brain function. The findings may improve understanding of the relationship between oral rehabilitation and overall health in older adults with complete tooth loss.
Read the detailed description
Complete edentulism is associated with impaired masticatory function, altered nutritional intake, reduced oral health-related quality of life, and potential deterioration in systemic health. Previous studies have suggested associations between tooth loss, accelerated biological aging, physical frailty, cognitive decline, and alterations in brain structure and function. However, prospective longitudinal evidence regarding changes in biological aging and brain function following full-arch implant-supported fixed dental rehabilitation remains limited.
This study is a prospective, longitudinal, observational cohort study designed to investigate the association between full-arch implant-supported fixed dental rehabilitation and changes in biological aging, physical frailty, cognitive function, and brain function among adults with complete edentulism.
The study will be conducted at the Department of Oral Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. A total of 60 adults aged 50 years or older with complete edentulism will be enrolled.
Participants will be classified into two cohorts according to their voluntary treatment decisions and routine clinical arrangements:
Implant Rehabilitation Cohort (n=30): Patients with complete edentulism who elect to undergo full-arch implant-supported fixed dental rehabilitation without an additional voluntary treatment delay.
Delayed-Treatment Comparison Cohort (n=30): Patients with complete edentulism who voluntarily elect to postpone full-arch implant-supported fixed dental rehabilitation for approximately three months.
Treatment decisions and the timing of implant rehabilitation will be determined independently of the research protocol. The investigators will not assign participants to treatment groups or determine treatment timing for research purposes. All implant procedures and prosthetic rehabilitation will be performed according to routine clinical indications and standard clinical practice.
The primary objective is to evaluate longitudinal changes in biological age acceleration, defined as the difference between saliva DNA methylation-derived biological age and chronological age, and to compare these changes between the two cohorts.
Secondary objectives include evaluating longitudinal changes in facial biological age, physical frailty, nutritional status, oral health-related quality of life, psychological well-being, cognitive performance, fine motor function, and brain structure and function. The study will also explore associations between changes in oral function and changes in biological aging and neurological outcomes.
At baseline (T0), participants will undergo comprehensive assessments, including demographic characteristics, medical history, lifestyle factors, body mass index, oral health status, and clinical evaluation of complete edentulism.
Saliva samples will be collected for DNA methylation analysis to estimate biological age. Standardized facial photographs and three-dimensional facial scans will be obtained to evaluate facial biological age and morphological changes.
Physical function and frailty will be assessed using handgrip strength, gait speed, and the Fried frailty phenotype.
Patient-reported outcomes will include oral health-related quality of life measured using the Oral Health Impact Profile-14 (OHIP-14), nutritional assessments, anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7), and depressive symptoms assessed using the 15-item Geriatric Depression Scale (GDS-15).
Cognitive and fine motor function will be evaluated using the Montreal Cognitive Assessment (MoCA), Digit Symbol Substitution Test (DSST), and Pegboard Test.
Brain structure and function will be assessed using multimodal neurophysiological and neuroimaging techniques. Resting-state electroencephalography (EEG) will be used to evaluate spontaneous brain activity and functional connectivity. Magnetic resonance imaging (MRI), including structural T1-weighted imaging, T2-weighted fluid-attenuated inversion recovery (T2-FLAIR), diffusion tensor imaging (DTI), and resting-state functional MRI, will be used to investigate brain structure, white matter characteristics, and functional connectivity.
Functional near-infrared spectroscopy (fNIRS) will be performed during standardized chewing tasks under different chewing conditions to evaluate cortical hemodynamic responses, particularly in sensorimotor and prefrontal regions.
Participants in both cohorts will undergo longitudinal follow-up assessments at baseline and at approximately 3, 12, and 24 months after baseline. Assessments will include repeated measurements of biological aging markers, facial biological age, physical function, patient-reported outcomes, cognitive performance, and brain function. Clinical information regarding implant rehabilitation, occlusal function, masticatory efficiency, prosthesis use, and complications will also be recorded as applicable.
Longitudinal changes in the primary and secondary outcomes will be analyzed using linear mixed-effects models incorporating cohort, time, and cohort-by-time interaction terms, with participant-specific random effects. Multivariable analyses will account for potential confounding factors, including baseline age, body mass index, lifestyle characteristics, and underlying medical conditions. Available longitudinal observations will be retained in the analysis, and missing-data patterns will be examined with sensitivity analyses or multiple imputation when appropriate.
This study aims to provide prospective observational evidence regarding the relationships among full-arch implant-supported fixed dental rehabilitation, biological aging, physical function, cognitive performance, and brain function in adults with complete edentulism. The findings may contribute to a broader understanding of the potential systemic and neurological associations of restoring oral function in patients with complete tooth loss.
- Conditions
- Edentulism, Biological Aging
- Being tested
- Full-Arch Implant-Supported Fixed Dental Rehabilitation
- Keywords
- Edentulism, Full-Arch Implant-Supported Fixed Prosthesis, Biological Aging, DNA Methylation Age, Cognitive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-Arch Implant-Supported Fixed Dental RehabilitationProcedure or surgery
Full-arch implant-supported fixed dental rehabilitation is performed according to routine clinical indications and standard clinical practice. Treatment includes preoperative assessment, individualized implant treatment planning, dental implant placement, fabrication and delivery of implant-supported fixed prostheses, and postoperative clinical follow-up.
The decision to undergo treatment and the timing of rehabilitation are determined by the participants and their treating clinicians independently of the research protocol. Participants in the delayed-treatment comparison cohort voluntarily postpone treatment for approximately three months. The investigators do not assign treatment or determine treatment timing for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Implant Rehabilitation Cohort | Participants with complete edentulism who voluntarily choose to undergo full-arch implant-supported fixed dental rehabilitation without an additional treatment delay. Treatment decisions are made independently of the research protocol according to patient preferences and routine clinical practice. Participants will undergo longitudinal assessments of biological aging, physical function, cognitive performance, and brain function. Receives: Procedure: Full-Arch Implant-Supported Fixed Dental Rehabilitation | |
| Delayed-Treatment Comparison Cohort | Participants with complete edentulism who voluntarily choose to postpone full-arch implant-supported fixed dental rehabilitation for approximately three months. The decision to delay treatment is made by the participants independently of the research protocol. These participants will serve as a delayed-treatment comparison cohort and undergo longitudinal assessments of biological aging, physical function, cognitive performance, and brain function. Receives: Procedure: Full-Arch Implant-Supported Fixed Dental Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary DNA Methylation Age Acceleration
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Secondary outcomes (14)
Change in Facial Biological Age Acceleration
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Handgrip Strength
Handgrip strength will be measured using a standardized grip strength assessment. Longitudinal changes in handgrip strength will be evaluated.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Gait Speed
Gait speed will be assessed using a standardized walking assessment to evaluate longitudinal changes in physical performance.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Physical Frailty
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Oral Health-Related Quality of Life
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Nutritional Status
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Anxiety Symptoms Assessed by the Beck Anxiety Inventory (BAI)
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Global Cognitive Function
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Information Processing Speed
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Fine Motor Function
Fine motor function will be assessed using a standardized Pegboard Test. Changes in test performance will be evaluated longitudinally.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Resting-State EEG Measures
Resting-state electroencephalography (EEG) will be used to assess changes in spontaneous brain activity and functional connectivity over time.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Brain Structure and Functional Connectivity
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Change in Cortical Hemodynamic Responses During Chewing
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.
Measured: Baseline, 3 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junyu Shi
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Sponsor-investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890753
- Sponsor's protocol ID
- SH9H-2026-T559-2
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Full-Arch Implant-Supported Fixed Prosthetic Rehabilitation and Biological Aging in Edentulous Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07890753
- Acronym / sponsor ID
- SH9H-2026-T559-2
- Conditions
- Edentulism, Biological Aging
- Keywords
- Edentulism, Full-Arch Implant-Supported Fixed Prosthesis, Biological Aging, DNA Methylation Age, Cognitive Function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Junyu ShiUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the association between full-arch implant-supported fixed dental rehabilitation and changes in biological aging among adults with complete tooth loss (edentulism).
A total of 60 adults aged 50 years or older with complete tooth loss will be enrolled in this prospective cohort study. Participants will be included in one of two groups: an implant rehabilitation group (30 participants) receiving full-arch implant-supported fixed dental prostheses, and a delayed-treatment comparison group (30 participants) receiving the same treatment after a three-month delay.
The main outcome is the change in biological age estimated from DNA methylation in saliva samples, compared with chronological age. Other outcomes include facial biological age, physical frailty, quality of life, nutritional status, emotional well-being, cognitive function, and brain function.
Participants will undergo assessments at baseline and at 3, 12, and 24 months. These assessments will include saliva collection, facial photographs and scans, physical function tests, questionnaires, cognitive tests, and brain function measurements using electroencephalography (EEG), magnetic resonance imaging (MRI), and functional near-infrared spectroscopy (fNIRS).
The study will examine whether changes in oral function following implant-supported fixed dental rehabilitation are associated with changes in biological aging and brain function. The findings may improve understanding of the relationship between oral rehabilitation and overall health in older adults with complete tooth loss.
Detailed description
Complete edentulism is associated with impaired masticatory function, altered nutritional intake, reduced oral health-related quality of life, and potential deterioration in systemic health. Previous studies have suggested associations between tooth loss, accelerated biological aging, physical frailty, cognitive decline, and alterations in brain structure and function. However, prospective longitudinal evidence regarding changes in biological aging and brain function following full-arch implant-supported fixed dental rehabilitation remains limited.
This study is a prospective, longitudinal, observational cohort study designed to investigate the association between full-arch implant-supported fixed dental rehabilitation and changes in biological aging, physical frailty, cognitive function, and brain function among adults with complete edentulism.
The study will be conducted at the Department of Oral Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. A total of 60 adults aged 50 years or older with complete edentulism will be enrolled.
Participants will be classified into two cohorts according to their voluntary treatment decisions and routine clinical arrangements:
Implant Rehabilitation Cohort (n=30): Patients with complete edentulism who elect to undergo full-arch implant-supported fixed dental rehabilitation without an additional voluntary treatment delay.
Delayed-Treatment Comparison Cohort (n=30): Patients with complete edentulism who voluntarily elect to postpone full-arch implant-supported fixed dental rehabilitation for approximately three months.
Treatment decisions and the timing of implant rehabilitation will be determined independently of the research protocol. The investigators will not assign participants to treatment groups or determine treatment timing for research purposes. All implant procedures and prosthetic rehabilitation will be performed according to routine clinical indications and standard clinical practice.
The primary objective is to evaluate longitudinal changes in biological age acceleration, defined as the difference between saliva DNA methylation-derived biological age and chronological age, and to compare these changes between the two cohorts.
Secondary objectives include evaluating longitudinal changes in facial biological age, physical frailty, nutritional status, oral health-related quality of life, psychological well-being, cognitive performance, fine motor function, and brain structure and function. The study will also explore associations between changes in oral function and changes in biological aging and neurological outcomes.
At baseline (T0), participants will undergo comprehensive assessments, including demographic characteristics, medical history, lifestyle factors, body mass index, oral health status, and clinical evaluation of complete edentulism.
Saliva samples will be collected for DNA methylation analysis to estimate biological age. Standardized facial photographs and three-dimensional facial scans will be obtained to evaluate facial biological age and morphological changes.
Physical function and frailty will be assessed using handgrip strength, gait speed, and the Fried frailty phenotype.
Patient-reported outcomes will include oral health-related quality of life measured using the Oral Health Impact Profile-14 (OHIP-14), nutritional assessments, anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7), and depressive symptoms assessed using the 15-item Geriatric Depression Scale (GDS-15).
Cognitive and fine motor function will be evaluated using the Montreal Cognitive Assessment (MoCA), Digit Symbol Substitution Test (DSST), and Pegboard Test.
Brain structure and function will be assessed using multimodal neurophysiological and neuroimaging techniques. Resting-state electroencephalography (EEG) will be used to evaluate spontaneous brain activity and functional connectivity. Magnetic resonance imaging (MRI), including structural T1-weighted imaging, T2-weighted fluid-attenuated inversion recovery (T2-FLAIR), diffusion tensor imaging (DTI), and resting-state functional MRI, will be used to investigate brain structure, white matter characteristics, and functional connectivity.
Functional near-infrared spectroscopy (fNIRS) will be performed during standardized chewing tasks under different chewing conditions to evaluate cortical hemodynamic responses, particularly in sensorimotor and prefrontal regions.
Participants in both cohorts will undergo longitudinal follow-up assessments at baseline and at approximately 3, 12, and 24 months after baseline. Assessments will include repeated measurements of biological aging markers, facial biological age, physical function, patient-reported outcomes, cognitive performance, and brain function. Clinical information regarding implant rehabilitation, occlusal function, masticatory efficiency, prosthesis use, and complications will also be recorded as applicable.
Longitudinal changes in the primary and secondary outcomes will be analyzed using linear mixed-effects models incorporating cohort, time, and cohort-by-time interaction terms, with participant-specific random effects. Multivariable analyses will account for potential confounding factors, including baseline age, body mass index, lifestyle characteristics, and underlying medical conditions. Available longitudinal observations will be retained in the analysis, and missing-data patterns will be examined with sensitivity analyses or multiple imputation when appropriate.
This study aims to provide prospective observational evidence regarding the relationships among full-arch implant-supported fixed dental rehabilitation, biological aging, physical function, cognitive performance, and brain function in adults with complete edentulism. The findings may contribute to a broader understanding of the potential systemic and neurological associations of restoring oral function in patients with complete tooth loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant Rehabilitation Cohort | – | Procedure: Full-Arch Implant-Supported Fixed Dental RehabilitationParticipants with complete edentulism who voluntarily choose to undergo full-arch implant-supported fixed dental rehabilitation without an additional treatment delay. Treatment decisions are made independently of the research protocol according to patient preferences and routine clinical practice. Participants will undergo longitudinal assessments of biological aging, physical function, cognitive performance, and brain function. |
| Delayed-Treatment Comparison Cohort | – | Procedure: Full-Arch Implant-Supported Fixed Dental RehabilitationParticipants with complete edentulism who voluntarily choose to postpone full-arch implant-supported fixed dental rehabilitation for approximately three months. The decision to delay treatment is made by the participants independently of the research protocol. These participants will serve as a delayed-treatment comparison cohort and undergo longitudinal assessments of biological aging, physical function, cognitive performance, and brain function. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 50 years or older with complete edentulism who seek care at the Department of Oral Implantology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, China. Eligible participants will be enrolled into two prospective observational cohorts according to their independently chosen treatment timing: an implant rehabilitation cohort and a delayed-treatment comparison cohort. Approximately 30 participants will be recruited into each cohort, for a total of 60 participants. Treatment decisions and timing will be determined by patients and their treating clinicians as part of routine clinical care, without assignment by the investigators.
Key inclusion criteria (6 listed)
- Patients with complete edentulism.
- Adults aged 50 years or older, regardless of sex.
- Ability and willingness to complete the scheduled assessments at T0, T1, T2, and T3.
- Eligibility for one of the following observational cohorts:
- Implant rehabilitation cohort: Patients with complete edentulism who are clinically eligible for full-arch implant-supported fixed dental rehabilitation and plan to undergo treatment.
Key exclusion criteria (4 listed)
- Systemic diseases that may substantially affect bone metabolism or biological aging, such as severe diabetes mellitus or osteoporosis.
- Recent use of bisphosphonates.
- Severe neurological disorders, major psychiatric disorders, or serious systemic diseases that may substantially affect cognitive function, brain structure or function, or systemic aging biomarkers.
- Any other condition or circumstance that prevents completion of the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-Arch Implant-Supported Fixed Dental RehabilitationFull-arch implant-supported fixed dental rehabilitation is performed according to routine clinical indications and standard clinical practice. Treatment includes preoperative assessment, individualized implant treatment planning, dental implant placement, fabrication and delivery of implant-supported fixed prostheses, and postoperative clinical follow-up. The decision to undergo treatment and the timing of rehabilitation are determined by the participants and their treating clinicians independently of the research protocol. Participants in the delayed-treatment comparison cohort voluntarily postpone treatment for approximately three months. The investigators do not assign treatment or determine treatment timing for research purposes. | Procedure or surgery | Delayed-Treatment Comparison Cohort, Implant Rehabilitation Cohort |
Primary outcome
Change in Salivary DNA Methylation Age Acceleration
Time frame: 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.
14 secondary outcomes
Change in Facial Biological Age Acceleration
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Handgrip Strength
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Gait Speed
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Physical Frailty
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Oral Health-Related Quality of Life
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Nutritional Status
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Anxiety Symptoms Assessed by the Beck Anxiety Inventory (BAI)
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Global Cognitive Function
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Information Processing Speed
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Fine Motor Function
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Resting-State EEG Measures
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Brain Structure and Functional Connectivity
Time frame: Baseline, 3 months, 12 months, and 24 months
Change in Cortical Hemodynamic Responses During Chewing
Time frame: Baseline, 3 months, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulism and Biological Aging, run by Junyu Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary DNA Methylation Age Acceleration (time frame: Baseline, 3 months, 12 months, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.