NCT06434506

Brief Summary

The Wire Syndrome problem referred to dental displacements that can be described as aberrant, inaccurate, unexplained, or excessive on teeth still contained by an intact orthodontic wire, without detachment or fracture, leading to evolving dental and periodontal, aesthetic and/or functional consequences. The objective of this study was to define the prevalence of mandibular wire syndrome and the associated risk factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

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

Study Start

First participant enrolled

July 2, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
Last Updated

February 17, 2025

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

January 29, 2024

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the Wire Syndrome

    The prevalence of wire syndrome is the number of people affected by the wire syndrome at a given time in a given population. The prevalence rate is calculated by dividing this number of cases by the size of the exposed population. This study was design as a cross-sectional study conducted in the Orthodontics Unit of the Nice University Hospital from July 2022 to July 2023.

    End : July 2023

Secondary Outcomes (6)

  • Identify risk factors associated with wire syndrome - questionnaire

    End : July 2023

  • Identify risk factors associated with wire syndrome - clinical examination periodontium

    End : July 2023

  • Identify risk factors associated with wire syndrome - clinical examination - Angle

    End : July 2023

  • Identify risk factors associated with wire syndrome - clinical examination: overbite / overjet

    End : July 2023

  • Identify risk factors associated with wire syndrome - clinical examination / presence/absence clinical signs

    End : July 2023

  • +1 more secondary outcomes

Study Arms (2)

NWS group

non-wire syndrome group

Other: no intervention

WS group

wire syndrome group

Other: no intervention

Interventions

No intervention

NWS groupWS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University who have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine

You may qualify if:

  • \- have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine.

You may not qualify if:

  • absence/fracture of orthodontic fixed mandibular retainer
  • wearing a removable mandibular retainer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 0600, France

Location

Study Officials

  • Carole Charavet

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

May 30, 2024

Study Start

July 2, 2022

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

February 17, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations