Orthodontic AppliancesNCT07127328
Benefits of an Orthodontic Device Removable Functional Appliance in the Management of Malocclusions/Orofacial Dysfunctions
An observational study of Orthodontic Appliances, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The removable functional appliance's goal is to restore functional balance (breathing, swallowing, chewing, etc.) and muscular balance (facial muscles, etc.) in the child. This promotes the establishment of a harmonious and stable occlusion.. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliances
- What is being tested?
- Patient with removable funcitonal appliance
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 30 Sep 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance.
Who may be able to join
- Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance
Who cannot join
- Patients who don't need a removable functionnal appliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of an Orthodontic Device (Removable Functional Appliance in the Management of Malocclusions/Orofacial Dysfunctions
The removable functional appliance's goal is to restore functional balance (breathing, swallowing, chewing, etc.) and muscular balance (facial muscles, etc.) in the child. This promotes the establishment of a harmonious and stable occlusion.. The objective of this study is to investigate the benefits of an orthodontic device (removable functional appliance ) in the management of malocclusions/orofacial dysfunctions
- Conditions
- Orthodontic Appliances
- Being tested
- Patient with removable funcitonal appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with removable funcitonal applianceDevice
Also called orthodontic treatment
Patients who have a malocclusion and/or a dysfunction treated by removable functional appliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvment of malocclusion dysfunctions with removable functional appliances
The improvment of malocclusion is evaluated with the observation of photography and videos with cephalometric analyze (Steiner).
Measured: A follow-up every 6 weeks for 6 months.
Correction of dysfunctions with removable functional appliances
The correction is evaluated with the observation of photography and videos with cephalometric analyze (Steiner).
Measured: A follow-up every 6 weeks for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Why it stopped: never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic AppliancesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127328
- Sponsor's protocol ID
- 25Odonto04
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of an Orthodontic Device (Removable Functional Appliance in the Management of Malocclusions/Orofacial Dysfunctions
- ClinicalTrials.gov ID
- NCT07127328
- Acronym / sponsor ID
- 25Odonto04
- Conditions
- Orthodontic Appliances
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 17 Aug 2025 (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.
The removable functional appliance's goal is to restore functional balance (breathing, swallowing, chewing, etc.) and muscular balance (facial muscles, etc.) in the child. This promotes the establishment of a harmonious and stable occlusion.. The objective of this study is to investigate the benefits of an orthodontic device (removable functional appliance ) in the management of malocclusions/orofacial dysfunctions
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance.
Key inclusion criteria (1 listed)
- Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance
Key exclusion criteria (1 listed)
- Patients who don't need a removable functionnal appliance.
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 |
|---|---|---|
| Patient with removable funcitonal applianceAlso: orthodontic treatmentPatients who have a malocclusion and/or a dysfunction treated by removable functional appliance | Device | – |
Primary outcome
Improvment of malocclusion dysfunctions with removable functional appliances
Time frame: A follow-up every 6 weeks for 6 months.
The improvment of malocclusion is evaluated with the observation of photography and videos with cephalometric analyze (Steiner).
Correction of dysfunctions with removable functional appliances
Time frame: A follow-up every 6 weeks for 6 months.
The correction is evaluated with the observation of photography and videos with cephalometric analyze (Steiner).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Orthodontic Appliances, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 22 Sep 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Improvment of malocclusion dysfunctions with removable functional appliances (time frame: A follow-up every 6 weeks for 6 months.). The study lists 2 primary outcomes in all. 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 22 Sep 2026.