Compliance, PatientNCT05155774
Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion
A study testing Twin block in people with Compliance, Patient and Treatment Adherence, run by Region Jönköping County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Compliance, Patient, Treatment Adherence
- What is being tested?
- Twin block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2018to 22 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy patients (ASA 1 and 2)
- Overjet of 6 mm or more
- Incomplete lip closure
Who cannot join
- Severe chronic conditions such as asthma or allergies
- Neuroopsychiatric disorders
- Craniofacial syndromes
- Previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Institute of Postgraduate Dentaln Education, department of orthodontics
Jönköping, Jönköping City Council, 55453
About this study
Official title: Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion - a Randomized Controlled Trial on Two Check-up Prescriptions
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.
Read the 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
- Being tested
- Twin block
- Keywords
- Orthodontic, Removable, Compliance, Adherence, Twin Block
- Medical subject headings
- Patient Compliance, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Twin block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From randomization to treatment completion, up to 24 months.
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.
Measured: 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
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.
Measured: From randomization to treatment completion, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Dec 2018
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compliance, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anders Magnusson, DDS, DMSc, Study chair, Institute of Postgraduate Dental Education, department of Orthodontics, Jönköping, SwedenMikael Sonesson, DDS, DMSc, Study chair, Orthodontic department, Faculty of odontology, Malmö University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155774
- Sponsor's protocol ID
- EPM 2017/382-31
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on data security in europe and if the data can be securely shared in accordance with GDPR
Publications
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.
PubMed 35968672
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion - a Randomized Controlled Trial on Two Check-up Prescriptions
- ClinicalTrials.gov ID
- NCT05155774
- Acronym / sponsor ID
- EPM 2017/382-31
- Conditions
- Compliance, Patient, Treatment Adherence
- Keywords
- Orthodontic, Removable, Compliance, Adherence, Twin Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Region Jönköping CountyOther government
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group, controlled every 6th week | Active comparator | Device: Twin blockThis group was controlled every 6th week, in accordance with what is deemed to be "golden standard" for treatment with a Twin Block orthodontic appliance. |
| Test group, controlled every 4th week | Experimental | Device: Twin blockThis group was controlled every 4th week, testing if a more frequent control interval would increase compliance with a Twin block orthodontic appliance. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy patients (ASA 1 and 2)
- Overjet of 6 mm or more
- Incomplete lip closure
Key exclusion criteria (4 listed)
- Severe chronic conditions such as asthma or allergies
- Neuroopsychiatric disorders
- Craniofacial syndromes
- Previous orthodontic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twin blockTwin 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 | Device | Control group, controlled every 6th week, Test group, controlled every 4th week |
Primary outcome
Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals
Time frame: 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.
3 secondary outcomes
Change in overjet, compared between participants randomized into two groups with different check up intervals
Time frame: From randomization to treatment completion, up to 24 months.
Change in overbite, compared between participants randomized into two groups with different check up intervals
Time frame: 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
Time frame: From randomization to treatment completion, up to 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 35968672Frilund 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.
- Individual participant dataSharing planned: Undecided. Depends on data security in europe and if the data can be securely shared in accordance with GDPR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Magnusson, DDS, DMSc study chair
Institute of Postgraduate Dental Education, department of Orthodontics, Jönköping, Sweden
Mikael Sonesson, DDS, DMSc study chair
Orthodontic department, Faculty of odontology, Malmö University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twin block in people with Compliance, Patient and Treatment Adherence, run by Region Jönköping County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals (time frame: From randomization to 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05155774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.