Skip to main content
OpenTrials
Completed

NCT Number: NCT04429113

Quad Helix and Correction of Mandibular Asymmetry

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxillary expansion with conventional Quad Helix bonded on molars.

Device

Maxillary expansion with conventional Quad Helix bonded on molars

Primary outcomes

  1. Difference in the mandibular corpus length between the right and left side

    Time frame: 1 day

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

Secondary outcomes

  1. Difference in the mandibular ramus height between the right and left side of the mandibule

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2020
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.