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Quad Helix and Correction of Mandibular Asymmetry

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ClinicalTrials.gov Identifier: NCT04429113
Recruitment Status : Completed
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.

Condition or disease Intervention/treatment
Mandibular Asymmetry Functional Shift of the Mandible Device: Maxillary expansion with conventional Quad Helix bonded on molars.

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 Design
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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 30, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
G1 or Early Group
Patients treated before age 7 (Quad Helix on decidual second molars)
 Device: Maxillary expansion with conventional Quad Helix bonded on molars.
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)
 Device: Maxillary expansion with conventional Quad Helix bonded on molars.
Maxillary expansion with conventional Quad Helix bonded on molars


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of Orthodontic Department of the CHU of Montpellier
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429113


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Manon Fourneron University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04429113    
Other Study ID Numbers: RECHMPL20_0350
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Early treatment
Posterior unilateral cross bite
Quad helix