Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorMalmö University
About this trial
The project involves a 10-year prospective longitudinal cohort multicentre study where orthodontic treatment and treatment effect is followed in children with Cl III due to maxillary retrognathia who undergo standardized orthodontic interceptive treatment. Standard clinical procedures are followed as usual at each clinic where standard diagnostic and follow up materials are taken before treatment, after treatment and follow ups after 5 and 10 years. The project will not introduce or test new treatment modalities, additional procedures or behavioural regulation in relation to normal clinical practice or new medical devices. The standard diagnostic and follow up materials in each clinic include examination of the dentition, occlusion, craniofacial morphology, and orofacial function. The analyses are based on the following standardized registration methods which are carried out on all the patients. Information from the patient record is included.
The patient related outcome measurements will be assessed by five different questionnaires. No biological material is collected for the project.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mandibular overjet due to maxillary retrognathia (Overjet </= 0 mm)
Age 9-12 years
Informed consent from parents/guardians
Disqualifiers
Mandibular overjet mainly due to mandibular prognathism
Known general and/or craniofacial syndromes/diseases
Adenoid vegetations, hypertrophic tonsils and significantly reduced air passage through nose (mouth breathing), which must be primarily treated
Functional disorders in muscles and jaw joints, which must be primarily treated
Trial design
Design model
Parallel
Treatments tested in this trial
Interceptive treatment
Other interventionControl
Treatment groups
180 Participants
are divided into 4 treatment groupsGroup A: tooth-borne devicesExperimental treatment 1 intervention
Group B: bone-borne devicesActive comparator 1 intervention
Group C: tooth extractionActive comparator 1 intervention
Group D: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in sagittal maxillary skeletal position
Sagittal maxillary skeletal position will be assessed using standardized lateral cephalometric radiographs. Cephalometric measurements reflecting anterior (mesial) displacement of the maxilla will be obtained at baseline during the mixed dentition stage and at follow-up in young adulthood. Changes in maxillary position will be compared among participants receiving different interceptive orthodontic treatments and untreated controls.
Time frame
Baseline (mixed dentition) to young adulthood, up to 10 years.Secondary outcomes
1
Oral health-related quality of life and Self-esteem
Oral health-related quality of life will be assessed using the Child Perceptions Questionnaire (CPQ). Questionnaire scores will be collected during annual follow-up visits and compared among treatment groups and untreated controls. Self-esteem will be assessed using validated patient-reported outcome questionnaires administered during annual follow-up visits. Changes in self-esteem scores will be compared among treatment groups and untreated controls.
Time frame
Baseline through young adulthood (up to 10 years) with start July 31 2026 to July 2028 until the end of the study.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Malmö University
Lead sponsor
University of Copenhagen
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: