Quad Helix and Correction of Mandibular Asymmetry

Completed

• Conditions: Mandibular Asymmetry; Functional Shift of the Mandible
• Interventions: Device: Maxillary expansion with conventional Quad Helix bonded on molars.

• Registration Number: NCT04429113
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed 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%.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G2 or Late Group	Maxillary expansion with conventional Quad Helix bonded on molars.	Patients treated between 7 and 13 years old (Quad Helix on first permanent molars)
G1 or Early Group	Maxillary expansion with conventional Quad Helix bonded on molars.	Patients treated before age 7 (Quad Helix on decidual second molars)

Primary Outcome Measures

Name	Time	Method
Difference in the mandibular corpus length between the right and left side	1 day	Difference in the mandibular corpus length between the right and left side : △L on conventional frontal x-ray.

Secondary Outcome Measures

Name	Time	Method
Difference in the mandibular ramus height between the right and left side of the mandibule	1 day	Difference in the mandibular ramus height between the right and left side of the mandibule : △H on conventional frontal x-ray.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France