Quad Helix and Correction of Mandibular Asymmetry

NCT ID: NCT04429113

Last Updated: 2020-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-08-30

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%.

Conditions

Mandibular Asymmetry; Functional Shift of the Mandible

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

G1 or Early Group

Patients treated before age 7 (Quad Helix on decidual second molars)

Maxillary expansion with conventional Quad Helix bonded on molars.

Intervention Type: DEVICE

Maxillary expansion with conventional Quad Helix bonded on molars

G2 or Late Group

Patients treated between 7 and 13 years old (Quad Helix on first permanent molars)

Maxillary expansion with conventional Quad Helix bonded on molars.

Intervention Type: DEVICE

Maxillary expansion with conventional Quad Helix bonded on molars

Interventions

Maxillary expansion with conventional Quad Helix bonded on molars.

Maxillary expansion with conventional Quad Helix bonded on molars

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manon Fourneron

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0350

Identifier Type: -

Identifier Source: org_study_id