Orthopedic DisorderNCT06327854
NUtrition and ORal Health in Orthopaedic Surgery
An observational study of Orthopedic Disorder and Metabolism and Nutrition Disorder, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Orthopedic Disorder, Metabolism and Nutrition Disorder
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 18 Mar 2024to 19 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients undergoing elective major orthopedic surgery, such as hip, knee, or spine surgery.
Who may be able to join
- Age ≥55
- Male and female gender
- Major elective orthopedic surgery (hip, knee, spinal)
- Signature of the informed consent
Who cannot join
- Inability to follow the study protocol
- Neuropsychiatric disease, developmental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Relationship Between Dietary Aspects and Oral Hygiene in Patients Undergoing Orthopedic Surgery
This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery).
- Medical subject headings
- Musculoskeletal Diseases, Nutrition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between pre-operative oral health and diet
Relationship between the objective oral health and the patient reported dietary score evaluated at hospital admission before major orthopedic surgery
Measured: Day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start18 Mar 2024
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Briguglio, Principal investigator, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327854
- Sponsor's protocol ID
- NUOROS (PI: M Briguglio)
- Other IDs
- L4175
- Status last verified
- Jul 2025
- First submitted
- 18 Mar 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between Dietary Aspects and Oral Hygiene in Patients Undergoing Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT06327854
- Acronym / sponsor ID
- NUOROS (PI: M Briguglio)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 25 Mar 2024 (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 prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients undergoing elective major orthopedic surgery, such as hip, knee, or spine surgery.
Key inclusion criteria (4 listed)
- Age ≥55
- Male and female gender
- Major elective orthopedic surgery (hip, knee, spinal)
- Signature of the informed consent
Key exclusion criteria (2 listed)
- Inability to follow the study protocol
- Neuropsychiatric disease, developmental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between pre-operative oral health and diet
Time frame: Day before surgery
Relationship between the objective oral health and the patient reported dietary score evaluated at hospital admission before major orthopedic surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- 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. This study is not recruiting at the moment.
Matteo Briguglio principal investigator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
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 Orthopedic Disorder and Metabolism and Nutrition Disorder, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 1 Aug 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association between pre-operative oral health and diet (time frame: Day before surgery). 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 1 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.