Class II Division 1 MalocclusionNCT02190630
Study to Measure the Effect of Part Time Versus Full Time Orthodontic Appliance Wear
A study testing Modified Clark Twin Block in people with Class II Division 1 Malocclusion, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Modified Clark Twin Block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Jul 2017
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Class II div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined),
- Overjet(horizontal difference between upper and lower front teeth) measuring minimum of 7mm,
- Male subjects 12--14 years at the start of treatment,
- Female subjects 11--13 years at start of treatment,
- Willingness of the patient and parent to participate in the study.
Who cannot join
- No previous orthodontic treatment
- No relevant medical history or craniofacial syndrome
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dental Insitiute Royal London Hospital
London, London, E1 1BB
About this study
Official title: A Prospective Randomised Controlled Trial Investigating the Skeletal and Dental Effects of a Removable Brace That Works on the Upper and Lower Teeth at the Same Time Worn Part Time Versus Full Time
The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.
Read the detailed description
Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. The reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.If this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.The investigators plan on recruiting 84 patients to the study and these subjects will be referred from hospital colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).
The study will be conducted in the Dental Institute at the Royal London Hospital, this hospital setting will be the sole site.
The study will last for 15 months from the time the last patient is recruited. Participants will undergo an initial records appointment where a radiograph and clinical measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be taken at 15months.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Modified Clark Twin Block
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Clark Twin BlockDevice
Also called Clark Twin Block, Twin Block, Functional Appliance
The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones
| Study group | Role | What they receive |
|---|---|---|
| Part time (12hour) wear | Active comparator | the' Modified Clark Twin Block' will be worn part time Receives: Device: Modified Clark Twin Block |
| Full time (24hour) wear | Active comparator | the ' Modified Clark Twin Block' will be worn full time Receives: Device: Modified Clark Twin Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
remaining overjet measured with an orthodontic ruler
the initial overjet will compared to the final overjet following 12 months of appliance treatment, and 3 months of relapse. overjet will be measured with an orthodontic ruler at every review appointment
Measured: outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period
Cephalometric Changes
Both linear and angular cephalometric changes will be assessed over this timeframe.
Measured: Outcome will be assessed after 12m of appliance wear and after 3 months of settling.
Secondary outcomes (1)
Comparison of subjective and objective measures of appliance wear
Subjective (patient completed time charts) and objective (theramon micro-sensor) measures of wear will be assessed over 12months of appliance wear.
Measured: 12 months of appliance wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
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 Class II Division 1 MalocclusionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Kate Counihan, BDS, Principal investigator, Queen Mary University of LondonJeet Parekh, BDS, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190630
- Sponsor's protocol ID
- ReDA Ref: 009038
- Status last verified
- Sep 2016
- First submitted
- 12 Mar 2014
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parekh J, Counihan K, Fleming PS, Pandis N, Sharma PK. Effectiveness of part-time vs full-time wear protocols of Twin-block appliance on dental and skeletal changes: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Feb;155(2):165-172. doi: 10.1016/j.ajodo.2018.07.016.
PubMed 30712687
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Trial Investigating the Skeletal and Dental Effects of a Removable Brace That Works on the Upper and Lower Teeth at the Same Time Worn Part Time Versus Full Time
- ClinicalTrials.gov ID
- NCT02190630
- Acronym / sponsor ID
- ReDA Ref: 009038
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Dec 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 15 Jul 2014 (estimated)
- 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.
The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.
Detailed description
Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. The reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.If this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.The investigators plan on recruiting 84 patients to the study and these subjects will be referred from hospital colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).
The study will be conducted in the Dental Institute at the Royal London Hospital, this hospital setting will be the sole site.
The study will last for 15 months from the time the last patient is recruited. Participants will undergo an initial records appointment where a radiograph and clinical measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be taken at 15months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part time (12hour) wear | Active comparator | Device: Modified Clark Twin Blockthe' Modified Clark Twin Block' will be worn part time |
| Full time (24hour) wear | Active comparator | Device: Modified Clark Twin Blockthe ' Modified Clark Twin Block' will be worn full time |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Class II div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined),
- Overjet(horizontal difference between upper and lower front teeth) measuring minimum of 7mm,
- Male subjects 12--14 years at the start of treatment,
- Female subjects 11--13 years at start of treatment,
- Willingness of the patient and parent to participate in the study.
Key exclusion criteria (2 listed)
- No previous orthodontic treatment
- No relevant medical history or craniofacial syndrome
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 |
|---|---|---|
| Modified Clark Twin BlockAlso: Clark Twin Block, Twin Block, Functional ApplianceThe Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones | Device | Full time (24hour) wear, Part time (12hour) wear |
Primary outcome
remaining overjet measured with an orthodontic ruler
Time frame: outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period
the initial overjet will compared to the final overjet following 12 months of appliance treatment, and 3 months of relapse. overjet will be measured with an orthodontic ruler at every review appointment
Cephalometric Changes
Time frame: Outcome will be assessed after 12m of appliance wear and after 3 months of settling.
Both linear and angular cephalometric changes will be assessed over this timeframe.
1 secondary outcome
Comparison of subjective and objective measures of appliance wear
Time frame: 12 months of appliance wear
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 30712687Parekh J, Counihan K, Fleming PS, Pandis N, Sharma PK. Effectiveness of part-time vs full-time wear protocols of Twin-block appliance on dental and skeletal changes: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Feb;155(2):165-172. doi: 10.1016/j.ajodo.2018.07.016.
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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.
Kate Counihan, BDS principal investigator
Queen Mary University of London
Jeet Parekh, BDS principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Clark Twin Block in people with Class II Division 1 Malocclusion, run by Queen Mary University of London at 1 site in United Kingdom.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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 United Kingdom. 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?
Results are not available in the source record.
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?
remaining overjet measured with an orthodontic ruler (time frame: outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period). The study lists 2 primary outcomes in all. 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 NCT02190630, 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 4 Jan 2017.