Class II Malocclusion, Division 1NCT04508322

Treatment of Class II Malocclusion With Excessive Overjet

A study testing HGA and FA in people with Class II Malocclusion, Division 1 and Orthodontic Appliances, run by Jenny Kallunki at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 8 to 10 years
Conditions the study is for: Class II Malocclusion, Division 1, Orthodontic Appliances, Quality of Life
What is being tested?: HGA and FA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteSweden
Study dates: 5 Dec 2013to Dec 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

The Center for Orthodontics and Pedodontics
Norrköping, Östergötland County, 60182

Other trials in Sweden

About this study

Official 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

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.

Read the 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)

Conditions: Class II Malocclusion, Division 1, Orthodontic Appliances, Quality of Life, Costs and Cost Analysis
Being tested: HGA, FA
Medical subject headings: Malocclusion, Angle Class II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HGADevice
Headgear Activator
FADevice
Fixed Orthodontic Appliance

Study groups in NCT04508322
Study group	Role	What they receive
Group 1	Active comparator	Early treatment HGA (9 years) Receives: Device: HGA; Device: FA
Group 2	Active comparator	Late treatment HGA (11 years) Receives: Device: HGA; Device: FA
Group 3	Active comparator	Treatment FA Receives: Device: FA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Change in Oral health related quality of life (OHRQoL)
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.
Measured: Through study completion (T0-T5), an average of two years between controls.
Societal costs
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.
Measured: During active treatment (T0-T3).
Change in tooth position and skeletal growth.
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.
Measured: Through study completion (T0-T5), an average of two years between controls.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 2013Dec 2030

First posted11 Aug 2020
Study start5 Dec 2013
Primary completionDec 2030 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Class II Malocclusion, Division 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04508322
Sponsor's protocol ID: Treatment of Class II maloccl.
Status last verified: Apr 2025
First submitted: 5 Aug 2020
Last updated: 17 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Batista KB, Thiruvenkatachari B, Harrison JE, O'Brien KD. Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents. Cochrane Database Syst Rev. 2018 Mar 13;3(3):CD003452. doi: 10.1002/14651858.CD003452.pub4.
PubMed 29534303
Dimberg L, Arnrup K, Bondemark L. The impact of malocclusion on the quality of life among children and adolescents: a systematic review of quantitative studies. Eur J Orthod. 2015 Jun;37(3):238-47. doi: 10.1093/ejo/cju046. Epub 2014 Sep 11.
PubMed 25214504
O'Brien K, Wright J, Conboy F, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I, Berk NW. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 2: Psychosocial effects. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):488-94; discussion 494-5. doi: 10.1016/S0889540603006425.
PubMed 14614414
Jokovic A, Locker D, Tompson B, Guyatt G. Questionnaire for measuring oral health-related quality of life in eight- to ten-year-old children. Pediatr Dent. 2004 Nov-Dec;26(6):512-8.
PubMed 15646914
Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Validity and reliability of a questionnaire for measuring child oral-health-related quality of life. J Dent Res. 2002 Jul;81(7):459-63. doi: 10.1177/154405910208100705.
PubMed 12161456
Kallunki J, Sollenius O, Paulsson L, Petren S, Dimberg L, Bondemark L. Oral health-related quality of life among children with excessive overjet or unilateral posterior crossbite with functional shift compared to children with no or mild orthodontic treatment need. Eur J Orthod. 2019 Mar 29;41(2):111-116. doi: 10.1093/ejo/cjy033.
PubMed 29878165
Kallunki J, Bondemark L, Paulsson L. Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial. Eur J Orthod. 2021 Dec 1;43(6):639-647. doi: 10.1093/ejo/cjaa073.
PubMed 33274388
Kallunki J, Bondemark L, Paulsson L. Comparisons of costs and treatment effects-an RCT on headgear activator treatment of excessive overjet in the mixed and late mixed dentition. Eur J Orthod. 2022 Jan 25;44(1):86-94. doi: 10.1093/ejo/cjab026.
PubMed 34041527

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
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Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
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LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Recruiting
EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
CLASS II DIVISION 1 MALOCCLUSION
Not yet recruiting
Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.
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All Class II Malocclusion, Division 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04508322
Acronym / sponsor ID: Treatment of Class II maloccl.
Conditions: Class II Malocclusion, Division 1, Orthodontic Appliances, Quality of Life, Costs and Cost Analysis
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 96 participants (actual)
Lead sponsor: Jenny KallunkiUniversity, hospital or other
Collaborators: Region Östergötland, Malmö University, Eklund foundation Malmö, Swedish Dental Associations Scientific Funds
Study start: 5 Dec 2013 (actual)
Primary completion: Dec 2030 (estimated)
Study completion: Dec 2030 (estimated)
First posted: 11 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1	Active comparator	Device: HGA, Device: FAEarly treatment HGA (9 years)
Group 2	Active comparator	Device: HGA, Device: FALate treatment HGA (11 years)
Group 3	Active comparator	Device: FATreatment FA

Who may qualify

Ages: 8 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HGAHeadgear Activator	Device	Group 1, Group 2
FAFixed Orthodontic Appliance	Device	Group 1, Group 2, Group 3

Primary outcome

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.

3 secondary outcomes

Change in Oral health related quality of life (OHRQoL)
Time frame: Through study completion (T0-T5), an average of two years between controls.
Societal costs
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
Background: PubMed 29534303Batista KB, Thiruvenkatachari B, Harrison JE, O'Brien KD. Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children and adolescents. Cochrane Database Syst Rev. 2018 Mar 13;3(3):CD003452. doi: 10.1002/14651858.CD003452.pub4.
Background: PubMed 25214504Dimberg L, Arnrup K, Bondemark L. The impact of malocclusion on the quality of life among children and adolescents: a systematic review of quantitative studies. Eur J Orthod. 2015 Jun;37(3):238-47. doi: 10.1093/ejo/cju046. Epub 2014 Sep 11.
Background: PubMed 14614414O'Brien K, Wright J, Conboy F, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I, Berk NW. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 2: Psychosocial effects. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):488-94; discussion 494-5. doi: 10.1016/S0889540603006425.
Background: PubMed 15646914Jokovic A, Locker D, Tompson B, Guyatt G. Questionnaire for measuring oral health-related quality of life in eight- to ten-year-old children. Pediatr Dent. 2004 Nov-Dec;26(6):512-8.
Background: PubMed 12161456Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Validity and reliability of a questionnaire for measuring child oral-health-related quality of life. J Dent Res. 2002 Jul;81(7):459-63. doi: 10.1177/154405910208100705.
Results publication: PubMed 29878165Kallunki J, Sollenius O, Paulsson L, Petren S, Dimberg L, Bondemark L. Oral health-related quality of life among children with excessive overjet or unilateral posterior crossbite with functional shift compared to children with no or mild orthodontic treatment need. Eur J Orthod. 2019 Mar 29;41(2):111-116. doi: 10.1093/ejo/cjy033.
Results publication: PubMed 33274388Kallunki J, Bondemark L, Paulsson L. Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial. Eur J Orthod. 2021 Dec 1;43(6):639-647. doi: 10.1093/ejo/cjaa073.
Results publication: PubMed 34041527Kallunki J, Bondemark L, Paulsson L. Comparisons of costs and treatment effects-an RCT on headgear activator treatment of excessive overjet in the mixed and late mixed dentition. Eur J Orthod. 2022 Jan 25;44(1):86-94. doi: 10.1093/ejo/cjab026.
Individual participant dataSharing planned: No

Related trials for Class II Malocclusion, Division 1

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Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jenny Kallunki, Orthodontist principal investigator

Malmö University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HGA and FA in people with Class II Malocclusion, Division 1 and Orthodontic Appliances, run by Jenny Kallunki at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04508322, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.