## Protocol Section
### Identification Module
**NCT ID:** NCT06434506

**Brief Title:** Prevalence of the Wire Syndrome

**Official Title:** Prevalence and Risk Factors Associated With Wire Syndrome

#### Organization Study ID Info
**ID:** 24Odonto01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2023-07-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-31

**Type:** ACTUAL

#### Start Date
**Date:** 2022-07-02

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-29
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nice

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Orthodontic Wires

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 59

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** non-wire syndrome group

**Intervention Names:**

- Other: no intervention

**Label:** NWS group

#### Arm Group 2

**Description:** wire syndrome group

**Intervention Names:**

- Other: no intervention

**Label:** WS group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- NWS group

- WS group

**Description:** No intervention

**Name:** no intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Prevalence of the Wire Syndrome

**Time Frame:** End : July 2023

#### Secondary Outcomes

**Description:** Questionnaire: 20 clinical questions without score

**Measure:** Identify risk factors associated with wire syndrome - questionnaire

**Time Frame:** End : July 2023

**Description:** Intraoral clinical examination:

type of periodontium: thin and scalloped or flat and thick

**Measure:** Identify risk factors associated with wire syndrome - clinical examination periodontium

**Time Frame:** End : July 2023

**Description:** Intraoral clinical examinations:

molar and canine relationships according to the Angle's classification class I, class II, Class III

**Measure:** Identify risk factors associated with wire syndrome - clinical examination - Angle

**Time Frame:** End : July 2023

**Description:** Intraoral clinical examinations:

overbite and overjet in milimeters

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

**Time Frame:** End : July 2023

**Description:** Intraoral clinical examinations:

presence/absence of an incisal guidance (YES / NO), presence/absence of parafunctions signs, (YES / NO)

**Measure:** Identify risk factors associated with wire syndrome - clinical examination / presence/absence clinical signs

**Time Frame:** End : July 2023

**Description:** Intraoral clinical examinations:

clinical signs: observations : swallowing and tongue (no score / no mesure : only clinical observations)

**Measure:** Identify risk factors associated with wire syndrome - clinical examination / description clinical signs

**Time Frame:** End : July 2023

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:-students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University

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

Exclusion Criteria:'- orthodontic treatment in progress

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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nice

**Country:** France

**Facility:** CHU NICE

**State:** Alpes Maritimes

**Zip:** 0600

#### Overall Officials

**Official 1:**

**Affiliation:** Centre Hospitalier Universitaire de Nice

**Name:** Carole Charavet

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
