NCT06327854

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

March 18, 2024

Last Update Submit

July 29, 2025

Conditions

Orthopedic DisorderMetabolism and Nutrition Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    Day before surgery

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Milan, Milan, Italy

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesNutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Matteo Briguglio

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

March 18, 2024

Primary Completion

February 19, 2025

Study Completion

February 19, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

IT(1)