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

87
On Track

Trial Health Score

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

Enrollment
53

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
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

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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

June 12, 2025

Last Update Submit

September 24, 2026

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 retrospective expert evaluation

  • severity classification of Wire Syndrome

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

    At retrospective expert evaluation

Secondary Outcomes (2)

  • Decisive clinical diagnostic criteria (Gwet's AC1)

    At retrospective expert evaluation

  • Non-decisive clinical diagnostic criteria (Gwet's AC1)

    At retrospective expert evaluation

Study Arms (2)

Retrospective case series 2 - WS and non-WS cases (n = 25)

Other: Non intervention

Retrospective case series 1 - WS cases (n = 28)

Other: Non intervention

Interventions

Non intervention

Retrospective case series 1 - WS cases (n = 28)Retrospective case series 2 - WS and non-WS cases (n = 25)

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

Related Publications (1)

  • Dridi SM, Aroca S, Antonarakis GS, Fontas E, Masucci C, Reners M, Roussarie F, de Sanctis M, Charavet C. Diagnosis of wire syndrome: A severity-based classification developed by a Multidisciplinary Working Group. Int Orthod. 2026 Jul 7;24(4):101207. doi: 10.1016/j.ortho.2026.101207. Online ahead of print.

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

January 31, 2026

Study Completion

January 31, 2026

Last Updated

September 28, 2026

Record last verified: 2026-09

Locations