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

NCT ID: NCT05155774

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-10-22

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.

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.

Conditions

Compliance, Patient; Treatment Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Twin block

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Twin block

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Jönköping County

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Magnusson, DDS, DMSc

Role: STUDY_CHAIR

Institute of Postgraduate Dental Education, department of Orthodontics, Jönköping, Sweden

Mikael Sonesson, DDS, DMSc

Role: STUDY_CHAIR

Orthodontic department, Faculty of odontology, Malmö University, Sweden

Locations

Institute of Postgraduate Dentaln Education, department of orthodontics

Jönköping, Jönköping City Council, Sweden

Countries

Sweden

References

Frilund E, Sonesson M, Magnusson A. Patient compliance with Twin Block appliance during treatment of Class II malocclusion: a randomized controlled trial on two check-up prescriptions. Eur J Orthod. 2023 Mar 31;45(2):142-149. doi: 10.1093/ejo/cjac046.

Reference Type: DERIVED

PMID: 35968672 (View on PubMed)

Other Identifiers

EPM 2017/382-31

Identifier Type: -

Identifier Source: org_study_id