Orthodontic WiresNCT06434506
Prevalence of the 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 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. 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
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2022to 30 Jul 2023
- 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: 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
Who may be able to join
None listed.
Who cannot join
- absence/fracture of orthodontic fixed mandibular retainer
- wearing a removable mandibular retainer.
- presence of craniofacial syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Risk Factors Associated With Wire Syndrome
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.
- Conditions
- Orthodontic Wires
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| NWS group | non-wire syndrome group Receives: Other: no intervention | |
| WS group | wire syndrome group Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Secondary outcomes (6)
Identify risk factors associated with wire syndrome - questionnaire
Questionnaire: 20 clinical questions without score
Measured: At inclusion
Identify risk factors associated with wire syndrome - clinical examination periodontium
Intraoral clinical examination:
type of periodontium: thin and scalloped or flat and thick
Measured: At inclusion
Identify risk factors associated with wire syndrome - clinical examination - Angle
Intraoral clinical examinations:
molar and canine relationships according to the Angle's classification class I, class II, Class III
Measured: At inclusion
Identify risk factors associated with wire syndrome - clinical examination: overbite / overjet
Intraoral clinical examinations:
overbite and overjet in milimeters
Measured: At inclusion
Identify risk factors associated with wire syndrome - clinical examination / presence/absence clinical signs
Intraoral clinical examinations:
presence/absence of an incisal guidance (YES / NO)
Measured: At inclusion
Identify risk factors associated with wire syndrome - clinical examination / description clinical signs
Intraoral clinical examinations:
clinical signs: observations : swallowing and tongue (no score / no mesure : only clinical observations)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start2 Jul 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole Charavet, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434506
- Sponsor's protocol ID
- 24Odonto01
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Prevalence and Risk Factors Associated With Wire Syndrome
- ClinicalTrials.gov ID
- NCT06434506
- Acronym / sponsor ID
- 24Odonto01
- Conditions
- Orthodontic Wires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 30 May 2024 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NWS group | – | Other: no interventionnon-wire syndrome group |
| WS group | – | Other: no interventionwire syndrome group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- absence/fracture of orthodontic fixed mandibular retainer
- wearing a removable mandibular retainer.
- presence of craniofacial syndromes
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 |
|---|---|---|
| no interventionNo intervention | Other | NWS group, WS group |
Primary outcome
Prevalence of the Wire Syndrome
Time frame: At inclusion
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.
6 secondary outcomes
Identify risk factors associated with wire syndrome - questionnaire
Time frame: At inclusion
Identify risk factors associated with wire syndrome - clinical examination periodontium
Time frame: At inclusion
Identify risk factors associated with wire syndrome - clinical examination - Angle
Time frame: At inclusion
Identify risk factors associated with wire syndrome - clinical examination: overbite / overjet
Time frame: At inclusion
Identify risk factors associated with wire syndrome - clinical examination / presence/absence clinical signs
Time frame: At inclusion
Identify risk factors associated with wire syndrome - clinical examination / description clinical signs
Time frame: At inclusion
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.
- Individual participant dataSharing planned: No
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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.
Carole Charavet principal investigator
Centre Hospitalier Universitaire de Nice
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 0 inclusion and 3 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?
Prevalence of the Wire Syndrome (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.