NCT07706400

Brief Summary

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.

Trial Health

67
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
146mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 31, 2026

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2038

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

12 years

First QC Date

April 21, 2026

Last Update Submit

July 13, 2026

Conditions

Maxillary RetrognathismChildrenTreatmentClass III Malocclusion

Keywords

Class III malocclusionmaxillary retrognathismmixed dentitionchildrenpermanent dentitionmaxillofacial surgeryFace mask

Outcome Measures

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.

    Baseline (mixed dentition) to young adulthood, up to 10 years.

Secondary Outcomes (1)

  • Oral health-related quality of life and Self-esteem

    Baseline through young adulthood (up to 10 years) with start July 31 2026 to July 2028 until the end of the study.

Study Arms (4)

tooth-borne devices

EXPERIMENTAL

tooth-borne, with and without facemask

Other: Interceptive treatment

bone-borne devices

ACTIVE COMPARATOR

bone-borne with and without mentoplates

Other: Interceptive treatment

tooth extraction

ACTIVE COMPARATOR

tooth extraction only

Other: Interceptive treatment

Control

NO INTERVENTION

orthodontic treatment is postponed until growth has ceased, after which extraction treatment or orthognathic surgery may be offered

Interventions

Interceptive treatmentOTHER

Control

bone-borne devicestooth extractiontooth-borne devices

Eligibility Criteria

Age9 Years - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mandibular overjet due to maxillary retrognathia (Overjet \</= 0 mm)
  • Age 9-12 years
  • Informed consent from parents/guardians

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Copenhagen

Copenhagen, Denmark, 2200, Denmark

Location

Faculty of Odontology

Malmö, Skåne County, 20506, Sweden

Location

Malmö University

Malmö, Skåne County, 20506, Sweden

Location

Related Publications (1)

  • 1. Hardy DK, Cubas YP, Orellana MF. Prevalence of angle class III malocclusion: A systematic review and meta-analysis. 2012. .

    BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Liselotte Sonnesen, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liselotte LS Sonnesen, Professor

CONTACT

+4535326670alson@sund.ku.dk

Mikael MS Sonesson, Assoc Prof.

CONTACT

+46406658447mikael.sonesson@mau.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 21, 2026

First Posted

July 15, 2026

Study Start

July 31, 2026

Primary Completion (Estimated)

July 31, 2038

Study Completion (Estimated)

July 31, 2038

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)SE(2)