NCT07127328

Brief 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.. The objective of this study is to investigate the benefits of an orthodontic device (removable functional appliance ) in the management of malocclusions/orofacial dysfunctions

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 17, 2025

Status Verified

July 1, 2025

Enrollment Period

29 days

First QC Date

August 11, 2025

Last Update Submit

August 11, 2025

Conditions

Orthodontic Appliances

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    A follow-up every 6 weeks for 6 months.

Interventions

Patient with removable funcitonal applianceDEVICE

Patients who have a malocclusion and/or a dysfunction treated by removable functional appliance

Also known as: orthodontic treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance.

You may qualify if:

  • Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance

You may not qualify if:

  • Patients who don't need a removable functionnal appliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Central Study Contacts

Carole Charavet

CONTACT

04 92 03 30 07charavet.c@chu-nice.fr

Rachida YATIMI

CONTACT

0492033007yatimi.r@chu-nice.fr

Study Design

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

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

September 1, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

August 17, 2025

Record last verified: 2025-07

Locations

FR(1)