Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion
Primary Purpose
Compliance, Patient, Treatment Adherence
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Twin block
Sponsored by
About this trial
This is an interventional treatment trial for Compliance, Patient focused on measuring Orthodontic, Removable, Compliance, Adherence, Twin Block
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
Sites / Locations
- Institute of Postgraduate Dentaln Education, department of orthodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group, controlled every 6th week
Test group, controlled every 4th week
Arm 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.
This group was controlled every 4th week, testing if a more frequent control interval would increase compliance with a Twin block orthodontic appliance.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in overjet, compared between participants randomized into two groups with different check up intervals
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
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
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.
Full Information
NCT ID
NCT05155774
First Posted
November 2, 2021
Last Updated
December 20, 2021
Sponsor
Region Jönköping County
1. Study Identification
Unique Protocol Identification Number
NCT05155774
Brief Title
Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion
Official Title
Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion - a Randomized Controlled Trial on Two Check-up Prescriptions
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 22, 2020 (Actual)
Study Completion Date
October 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Jönköping County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compliance, Patient, Treatment Adherence
Keywords
Orthodontic, Removable, Compliance, Adherence, Twin Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will check outcome on blinded study models.
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group, controlled every 6th week
Arm Type
Active Comparator
Arm 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.
Arm Title
Test group, controlled every 4th week
Arm Type
Experimental
Arm Description
This group was controlled every 4th week, testing if a more frequent control interval would increase compliance with a Twin block orthodontic appliance.
Intervention Type
Device
Intervention Name(s)
Twin block
Intervention Description
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
Primary Outcome Measure Information:
Title
Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals
Description
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.
Time Frame
From randomization to 12 months of treatment
Secondary Outcome Measure Information:
Title
Change in overjet, compared between participants randomized into two groups with different check up intervals
Description
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.
Time Frame
From randomization to treatment completion, up to 24 months.
Title
Change in overbite, compared between participants randomized into two groups with different check up intervals
Description
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.
Time Frame
From randomization to treatment completion, up to 24 months.
Title
Change in molar relationship, compared between participants randomized into two groups with different check up intervals
Description
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.
Time Frame
From randomization to treatment completion, up to 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Magnusson, DDS, DMSc
Organizational Affiliation
Institute of Postgraduate Dental Education, department of Orthodontics, Jönköping, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mikael Sonesson, DDS, DMSc
Organizational Affiliation
Orthodontic department, Faculty of odontology, Malmö University, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Postgraduate Dentaln Education, department of orthodontics
City
Jönköping
State/Province
Jönköping City Council
ZIP/Postal Code
55453
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depends on data security in europe and if the data can be securely shared in accordance with GDPR
Citations:
PubMed Identifier
35968672
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion
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