NCT04429113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

June 9, 2020

Last Update Submit

June 9, 2020

Conditions

Mandibular AsymmetryFunctional Shift of the Mandible

Keywords

Early treatmentPosterior unilateral cross biteQuad helix

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 day

Study Arms (2)

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.

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.

Interventions

Maxillary expansion with conventional Quad Helix bonded on molars.DEVICE

Maxillary expansion with conventional Quad Helix bonded on molars

G1 or Early GroupG2 or Late Group

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients of Orthodontic Department of the CHU of Montpellier

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete File
  • Inadequate quality of x-rays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Palatal Expansion Technique

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistry

Study Officials

  • Manon Fourneron

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 12, 2020

Study Start

February 1, 2017

Primary Completion

August 1, 2019

Study Completion

August 30, 2019

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations

FR(1)