Orthodondic AppliancesNCT07127341
A Survey on the Use of Removable Functional Appliances Among Patients Undergoing Treatment at the Orthodontic Unit of Nice University Hospital
An observational study of Orthodondic Appliances, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.
Trial summary
The aim of the removable functional appliance is to restore functional balance (breathing, swallowing, chewing, etc.) and muscular balance (particularly of the facial muscles) in children. This contributes to the development 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
- Orthodondic Appliances
- What is being tested?
- Patient with removable functional appliance
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2025to 1 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 under 18 years of age, prescribed ready-made orthodontic appliance, presence of a parent or legal guardian at the inclusion visit; for parents: parent or legal guardian of an included patient
Who may be able to join
- Patients under 18 years of age, prescribed ready-made orthodontic appliance, presence of a parent or legal guardian at the inclusion visit; for parents: parent or legal guardian of an included patient
Who cannot join
- Absence of a parent or legal guardian at inclusion; refusal by the patient or parent to participate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The aim of the removable functional appliance is to restore functional balance (breathing, swallowing, chewing, etc.) and muscular balance (particularly of the facial muscles) in children. This contributes to the development of a harmonious and stable occlusion. This study aims to evaluate the level of cooperation, satisfaction, and perceived effectiveness of treatment among patients and their parents.The aim of this survey is to assess patient and parent cooperation, satisfaction, and perceived treatment effectiveness used for their neuromuscular, orthopedic, and dental effects of removable elastomeric appliances(orthodontic appliances, functional)."
- Conditions
- Orthodondic Appliances
- Being tested
- Patient with removable functional appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with removable functional applianceDevice
Survey (quiz) for patient who had malocclusion and/or a dysfunction treated removable functional appliance about the treatment, before, during and after treatment
| Study group | Role | What they receive |
|---|---|---|
| Parents or patient with removable functional appliance | Not described Receives: Device: Patient with removable functional appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported experience/satisfaction of wearing a prefabricated functional orthodontic appliance
experience/satisfaction of patients is evaluated with a quiz (questionnaire) divided in three part : before, during and after treatment. (questions quizz patient) with scale from 0 to 10 and free answers. The questionnaire does not merely measure satisfaction: it also assesses, amongst other things, motivation, anxiety, pain, comfort, ease of use, integration into daily life, self-reported adherence and post-treatment perceptions.
Measured: Before treatment initiation, during appliance wear, and after the treatment period/completion
Parent-reported experience/satisfaction of the child wearing a prefabricated functional orthodontic appliance
experience/satisfaction of parents is evaluated with a quiz (questionnaire) divided in three part : before, during and after treatment. questions quizz parents with scale from 0 to 10 and free answers. The parent questionnaire covers several aspects of the experience and is not limited to satisfaction.
Measured: Before treatment initiation, during appliance wear, and after the treatment period/completion
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 May 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodondic 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
- Other
- Time perspective
- Prospective
- Enrolment
- 38 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
- NCT07127341
- Sponsor's protocol ID
- 25Odonto05
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2025
- Last updated
- 28 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey on the Use of Removable Functional Appliances Among Patients Undergoing Treatment at the Orthodontic Unit of Nice University Hospital
- ClinicalTrials.gov ID
- NCT07127341
- Acronym / sponsor ID
- 25Odonto05
- Conditions
- Orthodondic Appliances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- 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 aim of the removable functional appliance is to restore functional balance (breathing, swallowing, chewing, etc.) and muscular balance (particularly of the facial muscles) in children. This contributes to the development of a harmonious and stable occlusion. This study aims to evaluate the level of cooperation, satisfaction, and perceived effectiveness of treatment among patients and their parents.The aim of this survey is to assess patient and parent cooperation, satisfaction, and perceived treatment effectiveness used for their neuromuscular, orthopedic, and dental effects of removable elastomeric appliances(orthodontic appliances, functional)."
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents or patient with removable functional appliance | – | Device: Patient with removable functional appliance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients under 18 years of age, prescribed ready-made orthodontic appliance, presence of a parent or legal guardian at the inclusion visit; for parents: parent or legal guardian of an included patient
Key inclusion criteria (1 listed)
- Patients under 18 years of age, prescribed ready-made orthodontic appliance, presence of a parent or legal guardian at the inclusion visit; for parents: parent or legal guardian of an included patient
Key exclusion criteria (1 listed)
- Absence of a parent or legal guardian at inclusion; refusal by the patient or parent to participate
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 functional applianceSurvey (quiz) for patient who had malocclusion and/or a dysfunction treated removable functional appliance about the treatment, before, during and after treatment | Device | Parents or patient with removable functional appliance |
Primary outcome
Patient-reported experience/satisfaction of wearing a prefabricated functional orthodontic appliance
Time frame: Before treatment initiation, during appliance wear, and after the treatment period/completion
experience/satisfaction of patients is evaluated with a quiz (questionnaire) divided in three part : before, during and after treatment. (questions quizz patient) with scale from 0 to 10 and free answers. The questionnaire does not merely measure satisfaction: it also assesses, amongst other things, motivation, anxiety, pain, comfort, ease of use, integration into daily life, self-reported adherence and post-treatment perceptions.
Parent-reported experience/satisfaction of the child wearing a prefabricated functional orthodontic appliance
Time frame: Before treatment initiation, during appliance wear, and after the treatment period/completion
experience/satisfaction of parents is evaluated with a quiz (questionnaire) divided in three part : before, during and after treatment. questions quizz parents with scale from 0 to 10 and free answers. The parent questionnaire covers several aspects of the experience and is not limited to satisfaction.
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 28 Sep 2026.
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodondic Appliances, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.
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: finished, as of the sponsor's last update on 28 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 2 sites in Belgium, 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?
Patient-reported experience/satisfaction of wearing a prefabricated functional orthodontic appliance (time frame: Before treatment initiation, during appliance wear, and after the treatment period/completion). 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 28 Sep 2026.