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Active, Not Recruiting

NCT Number: NCT04508322

Treatment of Class II Malocclusion With Excessive Overjet

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Class II Malocclusion, Division 1 Costs and Cost Analysis Malocclusion Malocclusion, Angle Class II Orthodontic Appliances Quality of Life Stomatognathic Diseases Tooth Diseases

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Orthodontics and Pedodontics

Norrköping, Östergötland County, 60182, Sweden

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGA

Device

Headgear Activator

FA

Device

Fixed Orthodontic Appliance

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Jenny Kallunki

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Aug 11, 2020
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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