Oral HealthNCT06969092
A Study on the Correlation Between Oral Health and Delirium in Surgical Inpatients
An observational study of Oral Health, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Delirium is a clinical syndrome characterized by acute attention deficits, altered consciousness, and fluctuating cognitive dysfunction, typically triggered by multifactorial causes such as physical illness, medication use, or postoperative stress . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Oral Health
- What is being tested?
- Oral Frailty
- Type of treatment
- Pill or oral medicine
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 25 Mar 2026
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective cardiac surgery under general anesthesia requiring endotracheal intubation
Who may be able to join
- Patients aged ≥18 years scheduled for elective cardiac or thoracic surgery requiring endotracheal intubation.
- Patients without consciousness impairment, able to cooperate with the investigation.
- Patients or their legal guardians informed about the study's purpose, methodology, and content, with signed informed consent forms.
Who cannot join
- Patients with pre-existing oral conditions (e.g., xerostomia, oral mucosal lesions) prior to mechanical ventilation.
- Patients with a history of radiotherapy, chemotherapy, or corticosteroid use before surgery.
- Patients experiencing intraoperative mortality.
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, 1 recruiting
- Recruiting
Shanghai Xinhua hospital
Shanghai, Shanghai Municipality, 200092
Jinsong Li Li, 021-25076143
About this study
Delirium is a clinical syndrome characterized by acute attention deficits, altered consciousness, and fluctuating cognitive dysfunction, typically triggered by multifactorial causes such as physical illness, medication use, or postoperative stress . As the most common complication in hospitalized patients, delirium is highly prevalent among elderly surgical populations, with postoperative delirium (POD) occurring in 7.5%-27.5% of cases, and rates rising to 50%-70% in intensive care unit (ICU) patients . Its onset is closely associated with poor prognoses, including long-term postoperative cognitive decline , increased mortality, prolonged hospitalization, and elevated healthcare costs (annual costs in the United States ranging from 38billionto152 billion) . Early prevention and screening of POD are therefore critical to improving patient outcomes and reducing healthcare burdens.
Surgical patients' oral health issues exhibit multifactorial pathogenesis: intrinsic factors (e.g., age-related tooth loss, malnutrition-induced mucosal repair impairment, and chewing dysfunction due to reduced skeletal muscle mass) and iatrogenic factors (e.g., endotracheal intubation trauma, salivary secretion suppression from analgesics, and inadequate perioperative oral care). Poor oral health in hospitalized patients is often attributable to aging, physical dependence, cognitive decline, malnutrition, low skeletal muscle mass/strength, and comorbidities. The recently proposed concept of "Oral Frailty"-a progressive decline in oral structure and function-strongly predicts physical frailty, dysphagia, malnutrition, long-term care needs, and mortality in community-dwelling older adults
Read more
The impact of oral health on cognitive function may involve three pathways :
Mechanical pathway: Tooth loss disrupts masticatory motor function, reduces cerebral blood flow, and diminishes afferent stimulation from peripheral receptors (e.g., periodontal ligaments), leading to weakened neural connectivity and regional brain atrophy.
Neurodegenerative pathway: Tooth loss accelerates neuronal damage via apoptosis and mitophagy, increasing amyloid-beta deposition in the brain.
Inflammatory/metabolic pathway: Systemic inflammation, metabolic dysregulation, microbial-gut-brain axis interactions, and activation of microglia/astrocytes drive neuroinflammatory cascades in the central nervous system.
Given these connections, oral frailty may act as an independent risk factor distinct from general frailty and a potential contributor to POD. These findings suggest that oral frailty could serve as a unique biomarker for perioperative neurocognitive disorders, mediating their pathogenesis. Systematic investigation into the spatiotemporal relationship and mechanisms linking oral health to POD in surgical patients holds significant clinical value for developing multimodal prevention strategies.
- Conditions
- Oral Health
- Being tested
- Oral Frailty
- Keywords
- Oral Health, Oral Frailty, Surgical, Surgery, Delirium, Endotracheal Intubation, Cognitive Function
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral FrailtyOther
The exposure factor is the presence of oral frailty in patients before surgery, and oral frailty is evaluated using a scale.
| Study group | Role | What they receive |
|---|---|---|
| Oral Frailty Group | Not described Receives: Other: Oral Frailty | |
| Non-Oral Frailty Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
First, assess the patient's consciousness using the Richmond Agitation-Sedation Scale (RASS). This scale categorizes sedation levels into 10 grades, ranging from +4 (combative) to -5 (comatose), with each score corresponding to a distinct state of consciousness. Next, perform delirium assessment using the Confusion Assessment Method for the ICU (CAM-ICU).he Chinese version of CAM-ICU evaluates delirium through four domains:
- fluctuating Mental Status ②Attention Deficits
- Disorganized Thinking ④Altered Consciousness Clarity A delirium diagnosis is confirmed if criteria ① and ② are met, along with either ③ and/or ④.
Consciousness comprises two components: arousal level and awareness content. To assess delirium, begin by evaluating arousal level using the RASS. If the patient's RASS score is not -4 or -5 (indicating adequate arousal), proceed with delirium evaluation.
Measured: Within One Week Postoperatively
Secondary outcomes (3)
dysphagia
The Kubota Water Swallowing Test is used to evaluate a patient's swallowing function and is a classic bedside assessment method. The evaluation criteria are as follows:
The patient sits upright and drinks 30 mL of warm water. Observe the time required and presence of coughing during swallowing.
Grading and Criteria:
Grade 1 (Excellent): Swallows all 30 mL smoothly in one attempt without coughing.
Grade 2 (Good): Swallows in two or more attempts without coughing.
Grade 3 (Fair): Swallows in one attempt but with coughing.
Grade 4 (Poor): Swallows in two or more attempts with coughing.
Grade 5 (Very Poor): Frequent coughing, unable to swallow completely.
Interpretation of Swallowing Function:
Normal: Grade 1, completed within 5 seconds.
Suspicious: Grade 1 with completion time exceeding 5 seconds or Grade 2.
Abnormal: Grades 3-5.
Measured: 48 hours after removal of the endotracheal tube
appetite
The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess patients' appetite. It evaluates nutritional status by inquiring about appetite, food intake volume, perception of food taste, and related factors. For predicting the risk of 5% and 10% weight loss, the SNAQ demonstrates sensitivity and specificity of 81.3% and 76.4% (for 5%) and 88.2% and 83.5% (for 10%), respectively. The questionnaire comprises 6 items, each scored on a 1-5 point Likert scale. A total score <14 indicates a high-risk patient for weight loss, likely classified as an anorexic individual requiring intervention.
Measured: 48 hours after removal of the endotracheal tube
Serum albumin
Serum albumin is a mandatory laboratory test for postoperative patients, measured via blood sampling.
Measured: Postoperative serum albumin levels are routinely assessed within the first week after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 May 2025 (estimated)
- Primary completion25 Mar 2026 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies 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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969092
- Sponsor's protocol ID
- XH-25-004
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Correlation Between Oral Health and Delirium in Surgical Inpatients
- ClinicalTrials.gov ID
- NCT06969092
- Acronym / sponsor ID
- XH-25-004
- Conditions
- Oral Health
- Keywords
- Oral Health, Oral Frailty, Surgical, Surgery, Delirium, Endotracheal Intubation, Cognitive Function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 13 May 2025 (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.
Delirium is a clinical syndrome characterized by acute attention deficits, altered consciousness, and fluctuating cognitive dysfunction, typically triggered by multifactorial causes such as physical illness, medication use, or postoperative stress . As the most common complication in hospitalized patients, delirium is highly prevalent among elderly surgical populations, with postoperative delirium (POD) occurring in 7.5%-27.5% of cases, and rates rising to 50%-70% in intensive care unit (ICU) patients . Its onset is closely associated with poor prognoses, including long-term postoperative cognitive decline , increased mortality, prolonged hospitalization, and elevated healthcare costs (annual costs in the United States ranging from 38billionto152 billion) . Early prevention and screening of POD are therefore critical to improving patient outcomes and reducing healthcare burdens.
Surgical patients' oral health issues exhibit multifactorial pathogenesis: intrinsic factors (e.g., age-related tooth loss, malnutrition-induced mucosal repair impairment, and chewing dysfunction due to reduced skeletal muscle mass) and iatrogenic factors (e.g., endotracheal intubation trauma, salivary secretion suppression from analgesics, and inadequate perioperative oral care). Poor oral health in hospitalized patients is often attributable to aging, physical dependence, cognitive decline, malnutrition, low skeletal muscle mass/strength, and comorbidities. The recently proposed concept of "Oral Frailty"-a progressive decline in oral structure and function-strongly predicts physical frailty, dysphagia, malnutrition, long-term care needs, and mortality in community-dwelling older adults
The impact of oral health on cognitive function may involve three pathways :
Mechanical pathway: Tooth loss disrupts masticatory motor function, reduces cerebral blood flow, and diminishes afferent stimulation from peripheral receptors (e.g., periodontal ligaments), leading to weakened neural connectivity and regional brain atrophy.
Neurodegenerative pathway: Tooth loss accelerates neuronal damage via apoptosis and mitophagy, increasing amyloid-beta deposition in the brain.
Inflammatory/metabolic pathway: Systemic inflammation, metabolic dysregulation, microbial-gut-brain axis interactions, and activation of microglia/astrocytes drive neuroinflammatory cascades in the central nervous system.
Given these connections, oral frailty may act as an independent risk factor distinct from general frailty and a potential contributor to POD. These findings suggest that oral frailty could serve as a unique biomarker for perioperative neurocognitive disorders, mediating their pathogenesis. Systematic investigation into the spatiotemporal relationship and mechanisms linking oral health to POD in surgical patients holds significant clinical value for developing multimodal prevention strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Frailty Group | – | Other: Oral Frailty |
| Non-Oral Frailty Group | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective cardiac surgery under general anesthesia requiring endotracheal intubation
Key inclusion criteria (3 listed)
- Patients aged ≥18 years scheduled for elective cardiac or thoracic surgery requiring endotracheal intubation.
- Patients without consciousness impairment, able to cooperate with the investigation.
- Patients or their legal guardians informed about the study's purpose, methodology, and content, with signed informed consent forms.
Key exclusion criteria (3 listed)
- Patients with pre-existing oral conditions (e.g., xerostomia, oral mucosal lesions) prior to mechanical ventilation.
- Patients with a history of radiotherapy, chemotherapy, or corticosteroid use before surgery.
- Patients experiencing intraoperative mortality.
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 |
|---|---|---|
| Oral FrailtyThe exposure factor is the presence of oral frailty in patients before surgery, and oral frailty is evaluated using a scale. | Other | Oral Frailty Group |
Primary outcome
Delirium
Time frame: Within One Week Postoperatively
First, assess the patient's consciousness using the Richmond Agitation-Sedation Scale (RASS). This scale categorizes sedation levels into 10 grades, ranging from +4 (combative) to -5 (comatose), with each score corresponding to a distinct state of consciousness. Next, perform delirium assessment using the Confusion Assessment Method for the ICU (CAM-ICU).he Chinese version of CAM-ICU evaluates delirium through four domains: * fluctuating Mental Status ②Attention Deficits * Disorganized Thinking ④Altered Consciousness Clarity A delirium diagnosis is confirmed if criteria ① and ② are met, along with either ③ and/or ④. Consciousness comprises two components: arousal level and awareness content. To assess delirium, begin by evaluating arousal level using the RASS. If the patient's RASS score is not -4 or -5 (indicating adequate arousal), proceed with delirium evaluation.
3 secondary outcomes
dysphagia
Time frame: 48 hours after removal of the endotracheal tube
appetite
Time frame: 48 hours after removal of the endotracheal tube
Serum albumin
Time frame: Postoperative serum albumin levels are routinely assessed within the first week after surgery.
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 13 May 2025.
- Individual participant dataSharing planned: No
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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.
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 Oral Health, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 May 2025. 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?
Contact Aimin Shao, master (18796080248, 1224103064@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Within One Week Postoperatively). 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 13 May 2025.