NCT07030023

Brief Summary

The Wire Syndrome (WS) refers to aberrant, unexpected, unexplained, or excessive dental movements involving teeth held by an intact post-orthodontic retention wire. Its prevalence ranging from 1.1% to 43%. It is a chronic, progressive pathological process, generally asymptomatic, resulting in a new malocclusion that is not due to relapse or a physiological process, and whose aesthetic and/or functional dento-periodontal consequences are harmful. The causes are multifactorial origin. In the early stages of Wire Syndrome, dental and periodontal consequences are minors. These issues are thought to progressively worsen over time.However, to date, no author has proposed an appropriate diagnostic approach. Indeed, several diagnostic criteria have been reported in the literature, but their hierarchical ranking, in terms of importance and specificity, has yet to be determined. The main objective of this study is therefore to propose a classification of WS according to its severity, based on a shared framework between periodontists and orthodontists. This classification should, facilitate early detection of the syndrome, and reduce diagnostic delays and therapeutic errors. It should also help clarify prognosis and improve interprofessional collaboration in developing personalized treatment plans.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

June 19, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

June 12, 2025

Last Update Submit

June 12, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Presence of Wire Syndrome

    The presence of Wire Syndrome was clinically evaluated (based on photographs) under 2 answers "Yes" or "No".

    At the inclusion

  • severity classification of Wire Syndrome

    Severity was categorized into three grades such as minor, moderate, and severe based on dental and periodontal parameters.

    At the inclusion

Secondary Outcomes (2)

  • Major clinical diagnosis criteria (Fleiss Kappa)

    At the inclusion

  • Minor clinical diagnostis criteria (Fleiss Kappa)

    At the inclusion

Study Arms (1)

Wire syndrome patients

Other: Non intervention

Interventions

Non intervention

Wire syndrome patients

Eligibility Criteria

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

The study population consists of patients who have undergone orthodontic treatment and are currently wearing a fixed orthodontic retainer

You may qualify if:

  • Presence of fixed orthodontic retention (maxillary and/or mandible)
  • Comprehensive documentation available
  • Systemically healthy
  • Presence or not of a Wire Syndrome

You may not qualify if:

  • Patient with other orthodontic retention.
  • Patient unable to understand french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 06 000, France

Location

Study Design

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

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 19, 2025

Study Start

March 28, 2025

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

June 19, 2025

Record last verified: 2025-05

Locations