Treatment of Class II Malocclusion With Excessive Overjet

NCT04508322 | Active Not Recruiting

• 1 other identifier: Treatment of Class II maloccl.
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion (T0-T5), an average of two years between controls.

Secondary Outcomes (3)

• Change in Oral health related quality of life (OHRQoL)

  Through study completion (T0-T5), an average of two years between controls.

• Societal costs

  During active treatment (T0-T3).

• Change in tooth position and skeletal growth.

  Through study completion (T0-T5), an average of two years between controls.

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Early treatment HGA (9 years)

Device: HGA; Device: FA

Group 2

ACTIVE COMPARATOR

Late treatment HGA (11 years)

Device: HGA; Device: FA

Group 3

ACTIVE COMPARATOR

Treatment FA

Device: FA

Interventions

HGA DEVICE

Headgear Activator

Group 1; Group 2

FA DEVICE

Fixed Orthodontic Appliance

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jenny Kallunki: lead
• Region Östergötland: collaborator
• Malmö University: collaborator
• Eklund foundation Malmö: collaborator
• Swedish Dental Associations Scientific Funds: collaborator

Study Sites (1)

The Center for Orthodontics and Pedodontics

Norrköping, Östergötland County, 60182, Sweden

Location

Related Publications (8)

• Spandrio L. [Pre-analysis variability: the effect of evaporation on the error of measurement, with special reference to sodium and potassium]. Quad Sclavo Diagn. 1984 Mar;20(1):110-21. Italian.

  PMID: 6494411 BACKGROUND

• 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.

  PMID: 25214504 BACKGROUND

• 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.

  PMID: 29878165 BACKGROUND

• 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.

  PMID: 14614414 BACKGROUND

• 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.

  PMID: 15646914 BACKGROUND

• 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.

  PMID: 12161456 BACKGROUND

• 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.

  PMID: 33274388 BACKGROUND

• 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.

  PMID: 34041527 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jenny Kallunki, Orthodontist

  Malmö University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant Orthodontist. PhD-student

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 11, 2020
• Study Start: December 5, 2013
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)