Quad Helix and Correction of Mandibular Asymmetry

Functional Shift of the Mandible Clinical Trial

Official title:

Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429113
• Other study ID #: RECHMPL20_0350
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the effectiveness of the Quad Helix, an orthopaedic conventional appliance, in the correction of skeletal mandibular asymmetry, on frontal x-ray, in subjects treated before or after 7 years.

Description:

Introduction : Unilateral posterior crossbite (UPCB), often from dysfunctional and para-functional causes, leads to positional mandibular asymmetries that can develop at a very young age into skeletal mandibular deviation; hence the interest of early maxillary expansion. The purpose of this retrospective study was to compare the impact of maxillary expansion by Quad Helix (QH) on mandibular skeletal asymmetry correction before and after 7 years of age.

Materials and methods : All children with UPCB and skeletal mandibular asymmetry, who were treated by QH in the orthodontic department between February 2017 and August 2018 and who have done a radiography file at baseline (T0) and 12 months later (T1) have been included. The patients were divided into two groups according to age: under 7 years of age (early group G1) with QH adjusted on second primary molars and over up to 13 years old (late group G2) with QH adjusted on first permanent molars. The differences between the right and left sides of the mandible in corpus length L (main eligibility criterion) and ramus height H (secondary criterion) were compared between groups. X² test, Fisher's exact test and Wilcoxon rank-sum tests were used for baseline comparisons. A multifactorial analysis allowing adjustment on possible confounding factors was used with R software at a significance level of 5%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 30, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

Inclusion criteria:

• Unilateral Posterior Crossbite (at least one tooth) and skeletal mandibular asymmetry

• Treated by Quad Helix in the Orthodontic Department of the CHU Montpellier

• with frontal X-rays available at baseline and 12months later

Exclusion criteria:

• Incomplete File

• Inadequate quality of x-rays

Related Conditions & MeSH terms

• Functional Shift of the Mandible
• Mandibular Asymmetry

Intervention

Device:
• Maxillary expansion with conventional Quad Helix bonded on molars.
Maxillary expansion with conventional Quad Helix bonded on molars

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the mandibular corpus length between the right and left side	Difference in the mandibular corpus length between the right and left side : ?L on conventional frontal x-ray.	1 day
Secondary	Difference in the mandibular ramus height between the right and left side of the mandibule	Difference in the mandibular ramus height between the right and left side of the mandibule : ?H on conventional frontal x-ray.	1 day