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

Region Jönköping County

Status: Completed

Conditions: Treatment Adherence; Compliance, Patient

Treatments: Device: Twin block

Study type: Interventional

Funder types: Other

Identifiers

NCT05155774

EPM 2017/382-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Control group, controlled every 6th week

Active Comparator group

Description:

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.

Treatment:

Device: Twin block

Test group, controlled every 4th week

Experimental group

Description:

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

Treatment:

Device: Twin block