Orthodontic WiresNCT07030023
Diagnosis of Wire Syndrome
An observational study of Orthodontic Wires, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Wires
- What is being tested?
- Non intervention
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients who have undergone orthodontic treatment and are currently wearing a fixed orthodontic retainer
Who may be able to join
- Presence of fixed orthodontic retention (maxillary and/or mandible)
- Comprehensive documentation available
- Systemically healthy
- Presence or not of a Wire Syndrome
Who cannot join
- Patient with other orthodontic retention.
- Patient unable to understand french
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How to Diagnose Wire Syndrome ? A Classification Based on Retrospective Studies and Clinical Experience
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.
- Conditions
- Orthodontic Wires
- Being tested
- Non intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
Non intervention
| Study group | Role | What they receive |
|---|---|---|
| Retrospective case series 2 - WS and non-WS cases (n = 25) | Not described Receives: Other: Non intervention | |
| Retrospective case series 1 - WS cases (n = 28) | Not described Receives: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Wire Syndrome
The presence of Wire Syndrome was clinically evaluated (based on photographs) under 2 answers "Yes" or "No".
Measured: 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.
Measured: At retrospective expert evaluation
Secondary outcomes (2)
Decisive clinical diagnostic criteria (Gwet's AC1)
Gwet's AC1 coefficient : minimum value : <0 = no aggreeement; maximum value : > 0.8 = almost perfect.
Measured: At retrospective expert evaluation
Non-decisive clinical diagnostic criteria (Gwet's AC1)
Gwet's AC1 coefficient : minimum value : <0 = no aggreeement; maximum value : > 0.8 = almost perfect.
Measured: At retrospective expert evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start28 Mar 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic WiresStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030023
- Sponsor's protocol ID
- 25Ondonto03
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42413243
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Diagnose Wire Syndrome ? A Classification Based on Retrospective Studies and Clinical Experience
- ClinicalTrials.gov ID
- NCT07030023
- Acronym / sponsor ID
- 25Ondonto03
- Conditions
- Orthodontic Wires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients who have undergone orthodontic treatment and are currently wearing a fixed orthodontic retainer
Key inclusion criteria (4 listed)
- Presence of fixed orthodontic retention (maxillary and/or mandible)
- Comprehensive documentation available
- Systemically healthy
- Presence or not of a Wire Syndrome
Key exclusion criteria (2 listed)
- Patient with other orthodontic retention.
- Patient unable to understand french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionNon intervention | Other | Retrospective case series 1 - WS cases (n = 28), Retrospective case series 2 - WS and non-WS cases (n = 25) |
Primary outcome
Presence of Wire Syndrome
Time frame: At retrospective expert evaluation
The presence of Wire Syndrome was clinically evaluated (based on photographs) under 2 answers "Yes" or "No".
severity classification of Wire Syndrome
Time frame: At retrospective expert evaluation
Severity was categorized into three grades such as minor, moderate, and severe based on dental and periodontal parameters.
2 secondary outcomes
Decisive clinical diagnostic criteria (Gwet's AC1)
Time frame: At retrospective expert evaluation
Non-decisive clinical diagnostic criteria (Gwet's AC1)
Time frame: At retrospective expert evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 42413243Dridi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontic Wires, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Wire Syndrome (time frame: At retrospective expert evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07030023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.