Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion

Sponsor

Region Jönköping County (Other)

Overall Status

Completed

CT.gov ID

NCT05155774

Collaborator

(none)

Enrollment

Location

Arms

22.7

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the effect of two control intervals (once every 4th week or once every 6th week) on the wear time of a Twin Block removable appliance.

Condition or Disease	Intervention/Treatment	Phase
Compliance, Patient Treatment Adherence	Device: Twin block	N/A

Detailed Description

If the patient fulfill the inclusion criteria, they will be asked to participate in the study. After being informed about the study and the planned treatment, participants and their guardians will give their written consent to participate in the study.

Therafter they will be consecutively randomized into one of two groups with different control intervals, Group 1 (every 4th week) and Group 2 (every 6th week). They will recieve a clinical and radiological examination and then start treatment with a Twin Block appliance.

The Twin Block appliance will be fitted with a digital timer module to measure the wear time of the appliance objectively.

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The assessor will check outcome on blinded study models.

Primary Purpose:

Treatment

Official Title:

Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion - a Randomized Controlled Trial on Two Check-up Prescriptions

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Oct 22, 2020

Actual Study Completion Date :

Oct 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group, controlled every 6th week This group was controlled every 6th week, in accordance with what is deemed to be "golden standard" for treatment with a Twin Block orthodontic appliance.	Device: Twin block Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure
Experimental: Test group, controlled every 4th week This group was controlled every 4th week, testing if a more frequent control interval would increase compliance with a Twin block orthodontic appliance.	Device: Twin block Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure

Arm

Intervention/Treatment

Active Comparator: Control group, controlled every 6th week

This group was controlled every 6th week, in accordance with what is deemed to be "golden standard" for treatment with a Twin Block orthodontic appliance.

Device: Twin block

Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure

Experimental: Test group, controlled every 4th week

This group was controlled every 4th week, testing if a more frequent control interval would increase compliance with a Twin block orthodontic appliance.

Device: Twin block

Twin Block orthodontic appliance for treating patients with Angle class II molar relationship and a large horizontal overjet, often in combination with an incomplete lip closure

Outcome Measures

Primary Outcome Measures

Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals [From randomization to 12 months of treatment]
To measure if the wear time of the Twin Block appliance would increase if the control interval increased from once every 6th week to once every 4th week. The wear time was registered using the TheraMon system, and was measured in hours per day.

Secondary Outcome Measures

Change in overjet, compared between participants randomized into two groups with different check up intervals [From randomization to treatment completion, up to 24 months.]
To see if change in overjet would differ between or within the groups before and after treatment was finished. Horizontal overjet was measured in millimetres on study casts before and after treatment was finished.
Change in overbite, compared between participants randomized into two groups with different check up intervals [From randomization to treatment completion, up to 24 months.]
To see if change in overbite would differ between or within the groups before and after treatment. Overbite was measured in millimetres on study casts taken before and after treatment.
Change in molar relationship, compared between participants randomized into two groups with different check up intervals [From randomization to treatment completion, up to 24 months.]
To see how molar relationship would be differ between or within the two groups before and after treatment, measured in Angle classification on study casts before and after treatment completion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Healthy patients (ASA 1 and 2)
Overjet of 6 mm or more
Incomplete lip closure

Exclusion Criteria:

Severe chronic conditions such as asthma or allergies
Neuroopsychiatric disorders
Craniofacial syndromes
Previous orthodontic treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Postgraduate Dentaln Education, department of orthodontics	Jönköping	Jönköping City Council	Sweden	55453

Sponsors and Collaborators

Region Jönköping County

Investigators

Study Chair: Anders Magnusson, DDS, DMSc, Institute of Postgraduate Dental Education, department of Orthodontics, Jönköping, Sweden
Study Chair: Mikael Sonesson, DDS, DMSc, Orthodontic department, Faculty of odontology, Malmö University, Sweden