Treatment of Class II Malocclusion With Excessive Overjet

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04508322
• Other study ID #: Treatment of Class II maloccl.
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2013
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Region Östergötland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• HGA
Headgear Activator
• FA
Fixed Orthodontic Appliance

Locations

Country	Name	City	State
Sweden	The Center for Orthodontics and Pedodontics	Norrköping	Östergötland

Sponsors (5)

Lead Sponsor	Collaborator
Jenny Kallunki	Eklund foundation Malmö, Malmö University, Region Östergötland, Swedish Dental Associations Scientific Funds

Country where clinical trial is conducted

Sweden, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 treat — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Through study completion (T0-T5), an average of two years between controls.
Secondary	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.	During active treatment (T0-T3).
Secondary	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.	Through study completion (T0-T5), an average of two years between controls.