Mandibular AsymmetryNCT04429113
Quad Helix and Correction of Mandibular Asymmetry
An observational study of Mandibular Asymmetry and Functional Shift of the Mandible, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Mandibular Asymmetry, Functional Shift of the Mandible
- What is being tested?
- Maxillary expansion with conventional Quad Helix bonded on molars.
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients of Orthodontic Department of the CHU of Montpellier
Who may be able to join
- 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
Who cannot join
- Incomplete File
- Inadequate quality of x-rays
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study
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.
Read the 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%.
- Being tested
- Maxillary expansion with conventional Quad Helix bonded on molars.
- Keywords
- Early treatment, Posterior unilateral cross bite, Quad helix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary expansion with conventional Quad Helix bonded on molars.Device
Maxillary expansion with conventional Quad Helix bonded on molars
| Study group | Role | What they receive |
|---|---|---|
| G1 or Early Group | Patients treated before age 7 (Quad Helix on decidual second molars) Receives: 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) Receives: Device: Maxillary expansion with conventional Quad Helix bonded on molars. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Difference in the mandibular ramus height between the right and left side of the mandibule
Difference in the mandibular ramus height between the right and left side of the mandibule : △H on conventional frontal x-ray.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Feb 2017
- Primary completion1 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular AsymmetryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manon Fourneron, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429113
- Sponsor's protocol ID
- RECHMPL20_0350
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT04429113
- Acronym / sponsor ID
- RECHMPL20_0350
- Keywords
- Early treatment, Posterior unilateral cross bite, Quad helix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 or Early Group | – | Device: Maxillary expansion with conventional Quad Helix bonded on molars.Patients treated before age 7 (Quad Helix on decidual second molars) |
| G2 or Late Group | – | Device: Maxillary expansion with conventional Quad Helix bonded on molars.Patients treated between 7 and 13 years old (Quad Helix on first permanent molars) |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients of Orthodontic Department of the CHU of Montpellier
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Incomplete File
- Inadequate quality of x-rays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillary expansion with conventional Quad Helix bonded on molars.Maxillary expansion with conventional Quad Helix bonded on molars | Device | G1 or Early Group, G2 or Late Group |
Primary outcome
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.
1 secondary outcome
Difference in the mandibular ramus height between the right and left side of the mandibule
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manon Fourneron principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Asymmetry and Functional Shift of the Mandible, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the mandibular corpus length between the right and left side (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.