MedTrace Logo

Treatment of Class II Malocclusion With Excessive Overjet

NCT04508322 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-08-17

No results posted yet for this study

Summary

Class II malocclusion with excessive overjet is one of the most common malocclusions among children and adolescents. The overall goal of the project is to analyze orthodontic treatment of Class II malocclusion with excessive overjet when the treatment is started in different ages and treated with removable and/or fixed appliance.

Treatment initiated before the age of eleven is performed with a removable functional appliance, Headgear Activator (HGA). Treatment starting in early adolescence is performed with fixed orthodontic appliance (FA).

The hypotheses are:

* Treatment with HGA at the age of nine or eleven is effective. No spontaneous correction of the malocclusion is expected in the untreated control group.
* Patient experience, treatment effect and cost-effectiveness are equivalent whether the treatment with HGA is initiated at the age of nine or eleven.
* Treatment results, patient experience and treatment- and cost-effectiveness are equivalent whether treatment is initiated early with HGA or initiated in early adolescence with FA.
* The treatment of Class II malocclusion with excessive overjet renders long-term treatment stability and patient satisfaction.

Conditions

  • Class II Malocclusion, Division 1
  • Orthodontic Appliances
  • Quality of Life
  • Costs and Cost Analysis

Interventions

DEVICE

HGA

Headgear Activator

DEVICE

FA

Fixed Orthodontic Appliance

Sponsors & Collaborators

  • Region Östergötland

    collaborator OTHER

  • Malmö University

    collaborator OTHER

  • Eklund foundation Malmö

    collaborator UNKNOWN

  • Swedish Dental Associations Scientific Funds

    collaborator UNKNOWN

  • Jenny Kallunki

    lead OTHER

Principal Investigators

  • Jenny Kallunki, Orthodontist · Malmö University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-05
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508322 on ClinicalTrials.gov