Treatment of Class II Malocclusion With Excessive Overjet

August 13, 2025 updated by: Jenny Kallunki

Early and Late Treatment of Class II Malocclusion With Excessive Overjet- a Randomized Controlled Trial Regarding Treatment Results, Patient Experience and Treatment and Cost-effectiveness

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants (children, 9 years of age) are recruited at the orthodontic specialist clinic in Norrköping, Sweden.

After informed consent participants are randomized into Group 1, 2 or 3. After randomization and registration, treatment with HGA is initiated for Group 1.

Group 2 and 3 serves as untreated control group. Two years after registration, Group 2 starts treatment with HGA at the age of eleven.

Group 3 serves as untreated control group to treatment with HGA.

Four years after registration, Group 3 starts treatment with FA (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription).

The patients in group 1 and 2 in need of a second phase of orthodontic treatment are treated with FA (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription) in early adolescence.

The following registrations are made:

Study models, photographs (extraoral, intraoral), Lateral head radiographs (T0, T2, T5, if required T1, T3), Child perceptions questionnaire.

T0: After randomization; before treatment start (Group 1), registration/control (Group 2,3).

T1: Two years after T0; after finished treatment for (Group 1), before treatment start (Group 2), control/registration for (Group 3).

T2: Two years after T1; follow up (Group 1), after finished treatment (Group 2), before treatment start (Group 3).

T3: Approx two years after T2 for patients not undergoing treatment with FA. For patients treated with FA, when treatment is finished.

T4: Approx two years after T3- follow up.

T5: Approx 8-10 years after T0 (Long term follow-up)

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Norrköping, Östergötland, Sweden, 60182
        • The Center for Orthodontics and Pedodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eight to ten years of age at the start of the trial
  • mixed dentition;
  • Excessive overjet (≥ 6 mm) and first maxillary permanent molars in Class II malocclusion
  • No sucking habits or ceased sucking habits should have been evident at least one year before the trial was started.

Exclusion Criteria:

  • Craniofacial syndromes
  • Previous orthodontic treatment
  • Severe crowding of teeth, i.e. making the extraction of teeth necessary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Early treatment HGA (9 years)
Device: HGA
Headgear Activator
Device: FA
Fixed Orthodontic Appliance
Active Comparator: Group 2
Late treatment HGA (11 years)
Device: HGA
Headgear Activator
Device: FA
Fixed Orthodontic Appliance
Active Comparator: Group 3
Treatment FA
Device: FA
Fixed Orthodontic Appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in overjet; i.e change in tooth position during treatment. Assessment at follow up.
Time Frame: Through study completion (T0-T5), an average of two years between controls.
Tooth movement is assessed in millimeters by measures on study models.
Through study completion (T0-T5), an average of two years between controls.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral health related quality of life (OHRQoL)
Time Frame: Through study completion (T0-T5), an average of two years between controls.
Oral health related quality of life is assessed by the use of the Child Perceptions Questionnaire where 0 is minimal and 148 is maximum. Higher scores corresponds to poorer OHRQoL.
Through study completion (T0-T5), an average of two years between controls.
Societal costs
Time Frame: During active treatment (T0-T3).
Societal costs are the sum of indirect and direct treatment costs. Indirect treatment costs are travel costs for the patient and cost for parents when accompaning patients during treatment. Direct costs are clinical costs due to personnel and material.
During active treatment (T0-T3).
Change in tooth position and skeletal growth.
Time Frame: Through study completion (T0-T5), an average of two years between controls.
Tooth movement is assessed in millimeters by measures on study models. Skeletal growth is assessed in length and angular measures by cephalometric analysis of lateral radiographs.
Through study completion (T0-T5), an average of two years between controls.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jenny Kallunki

Collaborators

Region Östergötland
Malmö University
Eklund foundation Malmö
Swedish Dental Associations Scientific Funds

Investigators

  • Principal Investigator: Jenny Kallunki, Orthodontist, Malmö University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2013

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment of Class II maloccl.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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