Clinical trial NCT04508322: Treatment of Class II Malocclusion With Excessive Overjet
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Class II Malocclusion, Division 1
Orthodontic Appliances
Quality of Life
Costs and Cost Analysis
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Region Östergötland
name: Malmö University
name: Eklund foundation Malmö
name: Swedish Dental Associations Scientific Funds
First posted: 2020-08-11
Enrollment: 96
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in overjet; i.e change in tooth position during treatment. Assessment at follow up.
timeFrame: Through study completion (T0-T5), an average of two years between controls.
Secondary outcomes:
measure: Change in Oral health related quality of life (OHRQoL)
timeFrame: Through study completion (T0-T5), an average of two years between controls.
measure: Societal costs
timeFrame: During active treatment (T0-T3).
measure: Change in tooth position and skeletal growth.
timeFrame: Through study completion (T0-T5), an average of two years between controls.
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: The Center for Orthodontics and Pedodontics
state: Östergötland
Study officials:
affiliation: Malmö University
name: Jenny Kallunki, Orthodontist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.