Malocclusion, Angle Class IINCT03773783
Study to Compare Two Functional Appliances for Class II Malocclusions
A study testing Button and Bead appliance and Twin Block appliance in people with Malocclusion, Angle Class II, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
A randomised controlled clinical trial to compare the effectiveness of two functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth). Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Button and Bead appliance and Twin Block appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2017to Jul 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- * Overjet ≥ 7mm
- The normal overjet for a Caucasian population is in the range of 2-4mm. A functional appliance is used to allow for overjet reduction without extractions and/or to reduce the anchorage demands of the subsequent treatment with the Straight Wire Appliance (SWA). Clinically the overjet would need to be significantly increased for the treating clinician to consider the use of a functional appliance. Other similar studies have used an overjet of >6mm or ≥ 7mm. This study has elected for an initial overjet of ≥ 7mm to improve the studies external validity by making it more applicable to day-to-day clinical practice.
- The initial overjet will be used to select patients. The majority of recent high level trials and systematic reviews that have provided a significant amount of the evidence base in the treatment of Class II malocclusions have defined subjects according to their initial overjet.
- Age 10 to 14 years
- This has been selected to match other studies relating to functional appliance treatment and reflect the most common clinical practice. The literature on functional appliance treatment has provided evidence that on average the enhancement of growth is small. Some studies on the timing of functional appliance treatment have suggested that pubertal growth is not a significant factor in the success of functional appliance treatment but it is well know and accepted that functional appliance treatment is assisted during periods of more rapid growth. Numerous studies have also found better co-operation and completion of treatment in younger patients (Banks 2004, KOB 2003a \& 2003b)
- Satisfactory Dental health
- Patients must be dentally healthy and have a suitable level of oral health that would support orthodontic treatment, as per the British Orthodontic Society guidelines. They must have good oral hygiene with minimal gingivitis or periodontal disease, no dental caries or periapical pathology and no history of dento-alveolar trauma. This is judged by the investigator.
- Willing to participate in study and provide informed consent
Who cannot join
- * No previous orthodontic treatment or premolar extractions
- This is aimed at reducing any confounding factors within the study as these may affect the success of treatment.
- No craniofacial syndrome (including Cleft patients)
- This is aimed at reducing any confounding factors within the study as these conditions may affect the success of treatment. The treatment of this subgroup requires a multi-disciplinary team and is more complex. Their treatment pathway may vary from normal clinical practice.
Trial locations and contacts
1 site in 1 country.
Thomas Dietrich contact
United Kingdom1 site, 1 recruiting
- Recruiting
Birmingham dental hospital
Birmingham
Sheena Kotecha
About this study
Official title: Effectiveness of Treatment for Class II Malocclusions With the Button & Bead or Twin-block Functional Appliance: A Single Centre Randomised Clinical Trial
A randomised controlled clinical trial to compare the effectiveness of two functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).
Null hypothesis:
There is no significant difference between the Button \& bead and Twin-block appliances with regard to time taken to reduce the overjet
Read the detailed description
Background:
A functional appliance is a type of brace used to help correct a 'Class II' malocclusion. Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth. A functional appliance is defined as a brace that engages upper and lower teeth and works mainly by posturing the lower jaw away from its normal position1. The functional appliance may either be removable or fixed in nature and of various designs.
Correction of a class II malocclusion can be commenced early i.e. before the age of 10 or during early adolescence when the patient is in a late mixed dentition / early permanent dentition. If correction is commenced early, this results in the need for a two phase treatment which involves functional appliance treatment in the first phase (age 7-10) followed by fixed appliances (+/- functional appliances) as an adolescent (age 11-16). If correction is started in early adolescence only one phase of treatment is required which involves a combination of functional and fixed appliances (age 11-16).
Early or delayed class II treatment has been studied by various researchers2-10. O'Brien et al7 concluded that there was no advantage of early treatment with Twin Block as compared to treatment started in adolescents. In fact, they reported significantly poorer occlusal outcomes as determined by the objective Peer Assessment Rating (PAR) index in those that had early treatment. In addition, they found that total duration of treatment, total attendances and total cost of treatment was significantly higher in the early treatment group. The average total duration of treatment for those that had early treatment was 968 days (phase 1 = 527 days and phase 2 = 435 days) compared to 744 days for those that had treatment as an adolescent only.
The most commonly used brace to correct class II malocclusions in the UK is a functional appliance (Twin Block design) 11.
The Button and Bead functional appliance has been developed and used successfully by Mr Spary (Consultant Orthodontist) for several years. However, there are no studies to date that have studied its effectiveness in correcting a class II problem. The Button and bead appliance appears to be quicker at reducing the overjet and preferred by patients as there is less mouth opening making the appliance more comfortable to wear. It is also two clear aligners, which are more aesthetic than the traditional twin block appliance. The button and bead appliance does not however allow arch expansion. This may necessitate another appliance prior to fixed appliance treatment or prolong fixed appliance treatment if expansion also needs to be carried out in that phase.
Objectives:
- Primary objective:
- To compare the Button-\&-bead and Twin-block appliances treatment duration for overjet reduction
- Secondary objectives:
- To compare the Button-\&-bead and Twin-block appliances dento-occlusal outcomes as measured by the Peer Assessment Rating (PAR)
- To compare patient compliance with the Button-\&-bead and Twin-block appliances and identify causes for failure
- To compare the health economics of the Button-\&-bead and Twin-block appliances (Cost of appliances, number of visits, number and cost of repairs and/or replacements)
- To compare the skeletal changes of the Button-\&-bead and Twin-block appliances based on the Eastman analysis
- To compare changes in soft tissue profile as assessed by 3D photographs
- To assess changes in OHRQoL after overjet reduction with the Button-\&-bead and Twin-block appliances
- To evaluate and compare patient satisfaction with the Button-\&-bead and Twin-block appliances
- Safety objective
- To evaluate the safety of the Button-\&-Bead appliance relative to the Twin-Block appliance in terms of the occurrence of any device-related adverse- and side-effects (soft-tissue trauma, decalcification, dental caries, ingestion or aspiration of appliance).
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Button and Bead appliance, Twin Block appliance
- Keywords
- Myofunctional appliance
- 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.
Button and Bead applianceDevice
Button and Bead appliance
Twin Block applianceDevice
Twin Block appliance
| Study group | Role | What they receive |
|---|---|---|
| Twin Block | Active comparator | Twin Block appliance Receives: Device: Twin Block appliance |
| Button and Bead | Experimental | Button and Bead appliance Receives: Device: Button and Bead appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overjet reduction
How quickly the horizontal discrepancy between upper and lower incisor edges is reduced
Measured: Overjet measurement recorded at the start of treatment and at completion of functional appliance therapy 1 year later.
Secondary outcomes (7)
Change in Peer Assessment Rating (PAR)
PAR score change in terms of percentage and actual score
Measured: PAR score will be Assessed from the start of treatment models and the end of fixed appliance study models ( 2 years later)
Drop out
Percentage of patients dropping out of each arm of the trial
Measured: No. of patients at the start of functional appliance therapy that do not wish to continue within the trial or do not finish functional appliance therapy within 18 months
Skeletal changes
Compare skeletal changes of landmarks in degrees and millimetres using cephalometric x-rays at various time points
Measured: Cephalometric x-rays at start of treatment and at the end of treatment 1 year later
3D soft tissue measures
Measure changes in soft tissues using 3D photographs
Measured: 3D photographs at start of treatment and at the end of treatment (approx 1 year later)
Patient satisfaction
Use of tailored patient satisfaction questionnaire to assess patient satisfaction with both appliances
Measured: Patient satisfaction survey at study completion ( 1 year after treament started)
Child related Oral health quality of life (OHRQoL) questionnaire
Changes in OHRQoL
Measured: The patient ticked the applicable box for the 16 set questions from the standardised qualitative oral health questionairre. This was undertaken at the start of the trial and again at the end of functional appliance therapy ( approximately 1 year later)
Adverse events
Adverse events: decalcification, dental caries, soft tissue trauma, ingestion or aspiration of appliance
Measured: Adverse events over the course of functional appliance treatment ( recorded at every visit and reviewed at 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start10 Jul 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Dietrich, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773783
- Sponsor's protocol ID
- RG_16-204
- Status last verified
- Dec 2018
- First submitted
- 6 Oct 2017
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Isaacson KG, Reed RT, Stephens CD. Functional orthodontic appliances. Oxford: Blackwell Scientific Publications; 1990.
Tulloch JF, Phillips C, Proffit WR. Benefit of early Class II treatment: progress report of a two-phase randomized clinical trial. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):62-72, quiz 73-4. doi: 10.1016/S0889-5406(98)70277-X.
PubMed 9457020Keeling SD, Wheeler TT, King GJ, Garvan CW, Cohen DA, Cabassa S, McGorray SP, Taylor MG. Anteroposterior skeletal and dental changes after early Class II treatment with bionators and headgear. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):40-50. doi: 10.1016/S0889-5406(98)70275-6.
PubMed 9457018Ghafari J, Shofer FS, Jacobsson-Hunt U, Markowitz DL, Laster LL. Headgear versus function regulator in the early treatment of Class II, division 1 malocclusion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):51-61. doi: 10.1016/s0889-5406(98)70276-8.
PubMed 9457019O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.
PubMed 12923506O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.
PubMed 12970656O'Brien K, Wright J, Conboy F, Appelbe P, Davies L, Connolly I, Mitchell L, Littlewood S, Mandall N, Lewis D, Sandler J, Hammond M, Chadwick S, O'Neill J, McDade C, Oskouei M, Thiruvenkatachari B, Read M, Robinson S, Birnie D, Murray A, Shaw I, Harradine N, Worthington H. Early treatment for Class II Division 1 malocclusion with the Twin-block appliance: a multi-center, randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2009 May;135(5):573-9. doi: 10.1016/j.ajodo.2007.10.042.
PubMed 19409339Nelson C, Harkness M, Herbison P. Mandibular changes during functional appliance treatment. Am J Orthod Dentofacial Orthop. 1993 Aug;104(2):153-61. doi: 10.1016/S0889-5406(05)81005-4.
PubMed 8338068Illing HM, Morris DO, Lee RT. A prospective evaluation of Bass, Bionator and Twin Block appliances. Part I--The hard tissues. Eur J Orthod. 1998 Oct;20(5):501-16. doi: 10.1093/ejo/20.5.501.
PubMed 9825553Thiruvenkatachari B, Sandler J, Murray A, Walsh T, O'Brien K. Comparison of Twin-block and Dynamax appliances for the treatment of Class II malocclusion in adolescents: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):144.e1-9; discussion 144-5. doi: 10.1016/j.ajodo.2010.01.025.
PubMed 20691354Chadwick SM, Banks P, Wright JL. The use of myofunctional appliances in the UK: a survey of British orthodontists. Dent Update. 1998 Sep;25(7):302-8.
PubMed 10478026
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Treatment for Class II Malocclusions With the Button & Bead or Twin-block Functional Appliance: A Single Centre Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03773783
- Acronym / sponsor ID
- RG_16-204
- Conditions
- Malocclusion, Angle Class II
- Keywords
- Myofunctional appliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 12 Dec 2018 (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.
A randomised controlled clinical trial to compare the effectiveness of two functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).
Null hypothesis:
There is no significant difference between the Button \& bead and Twin-block appliances with regard to time taken to reduce the overjet
Detailed description
Background:
A functional appliance is a type of brace used to help correct a 'Class II' malocclusion. Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth. A functional appliance is defined as a brace that engages upper and lower teeth and works mainly by posturing the lower jaw away from its normal position1. The functional appliance may either be removable or fixed in nature and of various designs.
Correction of a class II malocclusion can be commenced early i.e. before the age of 10 or during early adolescence when the patient is in a late mixed dentition / early permanent dentition. If correction is commenced early, this results in the need for a two phase treatment which involves functional appliance treatment in the first phase (age 7-10) followed by fixed appliances (+/- functional appliances) as an adolescent (age 11-16). If correction is started in early adolescence only one phase of treatment is required which involves a combination of functional and fixed appliances (age 11-16).
Early or delayed class II treatment has been studied by various researchers2-10. O'Brien et al7 concluded that there was no advantage of early treatment with Twin Block as compared to treatment started in adolescents. In fact, they reported significantly poorer occlusal outcomes as determined by the objective Peer Assessment Rating (PAR) index in those that had early treatment. In addition, they found that total duration of treatment, total attendances and total cost of treatment was significantly higher in the early treatment group. The average total duration of treatment for those that had early treatment was 968 days (phase 1 = 527 days and phase 2 = 435 days) compared to 744 days for those that had treatment as an adolescent only.
The most commonly used brace to correct class II malocclusions in the UK is a functional appliance (Twin Block design) 11.
The Button and Bead functional appliance has been developed and used successfully by Mr Spary (Consultant Orthodontist) for several years. However, there are no studies to date that have studied its effectiveness in correcting a class II problem. The Button and bead appliance appears to be quicker at reducing the overjet and preferred by patients as there is less mouth opening making the appliance more comfortable to wear. It is also two clear aligners, which are more aesthetic than the traditional twin block appliance. The button and bead appliance does not however allow arch expansion. This may necessitate another appliance prior to fixed appliance treatment or prolong fixed appliance treatment if expansion also needs to be carried out in that phase.
Objectives:
- Primary objective:
- To compare the Button-\&-bead and Twin-block appliances treatment duration for overjet reduction
- Secondary objectives:
- To compare the Button-\&-bead and Twin-block appliances dento-occlusal outcomes as measured by the Peer Assessment Rating (PAR)
- To compare patient compliance with the Button-\&-bead and Twin-block appliances and identify causes for failure
- To compare the health economics of the Button-\&-bead and Twin-block appliances (Cost of appliances, number of visits, number and cost of repairs and/or replacements)
- To compare the skeletal changes of the Button-\&-bead and Twin-block appliances based on the Eastman analysis
- To compare changes in soft tissue profile as assessed by 3D photographs
- To assess changes in OHRQoL after overjet reduction with the Button-\&-bead and Twin-block appliances
- To evaluate and compare patient satisfaction with the Button-\&-bead and Twin-block appliances
- Safety objective
- To evaluate the safety of the Button-\&-Bead appliance relative to the Twin-Block appliance in terms of the occurrence of any device-related adverse- and side-effects (soft-tissue trauma, decalcification, dental caries, ingestion or aspiration of appliance).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twin Block | Active comparator | Device: Twin Block applianceTwin Block appliance |
| Button and Bead | Experimental | Device: Button and Bead applianceButton and Bead appliance |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- * Overjet ≥ 7mm
Key exclusion criteria (4 listed)
- * No previous orthodontic treatment or premolar extractions
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 |
|---|---|---|
| Button and Bead applianceButton and Bead appliance | Device | Button and Bead |
| Twin Block applianceTwin Block appliance | Device | Twin Block |
Primary outcome
Change in overjet reduction
Time frame: Overjet measurement recorded at the start of treatment and at completion of functional appliance therapy 1 year later.
How quickly the horizontal discrepancy between upper and lower incisor edges is reduced
7 secondary outcomes
Change in Peer Assessment Rating (PAR)
Time frame: PAR score will be Assessed from the start of treatment models and the end of fixed appliance study models ( 2 years later)
Drop out
Time frame: No. of patients at the start of functional appliance therapy that do not wish to continue within the trial or do not finish functional appliance therapy within 18 months
Skeletal changes
Time frame: Cephalometric x-rays at start of treatment and at the end of treatment 1 year later
3D soft tissue measures
Time frame: 3D photographs at start of treatment and at the end of treatment (approx 1 year later)
Patient satisfaction
Time frame: Patient satisfaction survey at study completion ( 1 year after treament started)
Child related Oral health quality of life (OHRQoL) questionnaire
Time frame: The patient ticked the applicable box for the 16 set questions from the standardised qualitative oral health questionairre. This was undertaken at the start of the trial and again at the end of functional appliance therapy ( approximately 1 year later)
Adverse events
Time frame: Adverse events over the course of functional appliance treatment ( recorded at every visit and reviewed at 1 year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- BackgroundIsaacson KG, Reed RT, Stephens CD. Functional orthodontic appliances. Oxford: Blackwell Scientific Publications; 1990.
- Background: PubMed 9457020Tulloch JF, Phillips C, Proffit WR. Benefit of early Class II treatment: progress report of a two-phase randomized clinical trial. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):62-72, quiz 73-4. doi: 10.1016/S0889-5406(98)70277-X.
- Background: PubMed 9457018Keeling SD, Wheeler TT, King GJ, Garvan CW, Cohen DA, Cabassa S, McGorray SP, Taylor MG. Anteroposterior skeletal and dental changes after early Class II treatment with bionators and headgear. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):40-50. doi: 10.1016/S0889-5406(98)70275-6.
- Background: PubMed 9457019Ghafari J, Shofer FS, Jacobsson-Hunt U, Markowitz DL, Laster LL. Headgear versus function regulator in the early treatment of Class II, division 1 malocclusion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):51-61. doi: 10.1016/s0889-5406(98)70276-8.
- Background: PubMed 12923506O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.
- Background: PubMed 12970656O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.
- Background: PubMed 19409339O'Brien K, Wright J, Conboy F, Appelbe P, Davies L, Connolly I, Mitchell L, Littlewood S, Mandall N, Lewis D, Sandler J, Hammond M, Chadwick S, O'Neill J, McDade C, Oskouei M, Thiruvenkatachari B, Read M, Robinson S, Birnie D, Murray A, Shaw I, Harradine N, Worthington H. Early treatment for Class II Division 1 malocclusion with the Twin-block appliance: a multi-center, randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2009 May;135(5):573-9. doi: 10.1016/j.ajodo.2007.10.042.
- Background: PubMed 8338068Nelson C, Harkness M, Herbison P. Mandibular changes during functional appliance treatment. Am J Orthod Dentofacial Orthop. 1993 Aug;104(2):153-61. doi: 10.1016/S0889-5406(05)81005-4.
- Background: PubMed 9825553Illing HM, Morris DO, Lee RT. A prospective evaluation of Bass, Bionator and Twin Block appliances. Part I--The hard tissues. Eur J Orthod. 1998 Oct;20(5):501-16. doi: 10.1093/ejo/20.5.501.
- Background: PubMed 20691354Thiruvenkatachari B, Sandler J, Murray A, Walsh T, O'Brien K. Comparison of Twin-block and Dynamax appliances for the treatment of Class II malocclusion in adolescents: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):144.e1-9; discussion 144-5. doi: 10.1016/j.ajodo.2010.01.025.
- Background: PubMed 10478026Chadwick SM, Banks P, Wright JL. The use of myofunctional appliances in the UK: a survey of British orthodontists. Dent Update. 1998 Sep;25(7):302-8.
- Individual participant dataSharing planned: No
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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.
Thomas Dietrich contact
Thomas Dietrich principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Button and Bead appliance and Twin Block appliance in people with Malocclusion, Angle Class II, run by University of Birmingham 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 8 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: status not confirmed, as of the sponsor's last update on 12 Dec 2018. 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?
Contact Sheena Kotecha, FDS MPhil ((+44)07940544164, drkotecha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overjet reduction (time frame: Overjet measurement recorded at the start of treatment and at completion of functional appliance therapy 1 year later.). 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 NCT03773783, which also lists 11 linked publications.
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 12 Dec 2018.