NUtrition and ORal Health in Orthopaedic Surgery

July 29, 2025 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults patients undergoing elective major orthopedic surgery, such as hip, knee, or spine surgery.

Description

Inclusion Criteria:

  • Age ≥55
  • Male and female gender
  • Major elective orthopedic surgery (hip, knee, spinal)
  • Signature of the informed consent

Exclusion Criteria:

  • Inability to follow the study protocol
  • Neuropsychiatric disease, developmental disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Investigators

  • Principal Investigator: Matteo Briguglio, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Actual)

February 19, 2025

Study Completion (Actual)

February 19, 2025

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUOROS (PI: M Briguglio)
  • L4175 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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