NCT05155774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
Last Updated

January 11, 2022

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

November 2, 2021

Last Update Submit

December 20, 2021

Conditions

Compliance, PatientTreatment Adherence

Keywords

OrthodonticRemovableComplianceAdherenceTwin Block

Outcome Measures

Primary Outcomes (1)

  • Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals

    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.

    From randomization to 12 months of treatment

Secondary Outcomes (3)

  • Change in overjet, compared between participants randomized into two groups with different check up intervals

    From randomization to treatment completion, up to 24 months.

  • Change in overbite, compared between participants randomized into two groups with different check up intervals

    From randomization to treatment completion, up to 24 months.

  • 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.

Study Arms (2)

Control group, controlled every 6th week

ACTIVE COMPARATOR

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

Test group, controlled every 4th week

EXPERIMENTAL

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

Interventions

Twin blockDEVICE

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

Control group, controlled every 6th weekTest group, controlled every 4th week

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Postgraduate Dentaln Education, department of orthodontics

Jönköping, Jönköping City Council, 55453, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 35968672DERIVED

MeSH Terms

Conditions

Patient ComplianceTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareHealth BehaviorBehavior

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will check outcome on blinded study models.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

December 14, 2021

Study Start

December 1, 2018

Primary Completion

October 22, 2020

Study Completion

October 22, 2020

Last Updated

January 11, 2022

Record last verified: 2021-11

Locations

SE(1)