Malocclusion, Angle Class II Clinical Trial
Official title:
Effectiveness of Treatment for Class II Malocclusions With the Button & Bead or Twin-block Functional Appliance: A Single Centre Randomised Clinical Trial
NCT number | NCT03773783 |
Other study ID # | RG_16-204 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 10, 2017 |
Est. completion date | July 2020 |
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
Status | Recruiting |
Enrollment | 64 |
Est. completion date | July 2020 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 14 Years |
Eligibility |
Inclusion Criteria: - * 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 Exclusion Criteria: - * 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham dental hospital | Birmingham |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham |
United Kingdom,
Chadwick 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. — View Citation
Ghafari 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. — View Citation
Illing 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. — View Citation
Isaacson KG, Reed RT, Stephens CD. Functional orthodontic appliances. Oxford: Blackwell Scientific Publications; 1990.
Keeling 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. Review. — View Citation
Nelson C, Harkness M, Herbison P. Mandibular changes during functional appliance treatment. Am J Orthod Dentofacial Orthop. 1993 Aug;104(2):153-61. — View Citation
O'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. — View Citation
O'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. — View Citation
O'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. — View Citation
Thiruvenkatachari 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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in overjet reduction | How quickly the horizontal discrepancy between upper and lower incisor edges is reduced | Overjet measurement recorded at the start of treatment and at completion of functional appliance therapy 1 year later. | |
Secondary | Change in Peer Assessment Rating (PAR) | PAR score change in terms of percentage and actual score | PAR score will be Assessed from the start of treatment models and the end of fixed appliance study models ( 2 years later) | |
Secondary | Drop out | Percentage of patients dropping out of each arm of the trial | 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 | |
Secondary | Skeletal changes | Compare skeletal changes of landmarks in degrees and millimetres using cephalometric x-rays at various time points | Cephalometric x-rays at start of treatment and at the end of treatment 1 year later | |
Secondary | 3D soft tissue measures | Measure changes in soft tissues using 3D photographs | 3D photographs at start of treatment and at the end of treatment (approx 1 year later) | |
Secondary | Patient satisfaction | Use of tailored patient satisfaction questionnaire to assess patient satisfaction with both appliances | Patient satisfaction survey at study completion ( 1 year after treament started) | |
Secondary | Child related Oral health quality of life (OHRQoL) questionnaire | Changes in OHRQoL | 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) | |
Secondary | Adverse events | Adverse events: decalcification, dental caries, soft tissue trauma, ingestion or aspiration of appliance | Adverse events over the course of functional appliance treatment ( recorded at every visit and reviewed at 1 year) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06297109 -
Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery
|
N/A | |
Recruiting |
NCT05227469 -
Myofunctional Therapy Twin Block
|
N/A | |
Completed |
NCT05356780 -
Predictability of Orthodontic Tooth Movement With Invisalign Aligners
|
||
Not yet recruiting |
NCT05467579 -
Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects
|
N/A | |
Completed |
NCT01530516 -
Crossbow Versus Forsus Springs in Mild to Moderate Class II Malocclusion Cases
|
N/A | |
Recruiting |
NCT04875104 -
Upper Sequential Distalization With TADs and Aligners
|
N/A | |
Not yet recruiting |
NCT05853211 -
Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skelettal Patterns
|
||
Completed |
NCT04175405 -
Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.
|
N/A | |
Completed |
NCT02456220 -
Dentoskeletal Changes Associated With Herbst Appliance Therapy
|
N/A | |
Recruiting |
NCT05950581 -
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
|
N/A | |
Completed |
NCT03645343 -
The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements
|
N/A | |
Completed |
NCT04276402 -
Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.
|
N/A | |
Completed |
NCT03239912 -
Treatment of Class II Malocclusion Combined With Low-level Laser
|
N/A | |
Recruiting |
NCT05499221 -
Bone Anchored Carriere Motion Appliance
|
N/A | |
Completed |
NCT03159962 -
Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects
|
N/A | |
Active, not recruiting |
NCT02010346 -
The Effect of Timing on Orthodontic Treatment
|
N/A | |
Completed |
NCT06240923 -
"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"
|
N/A | |
Completed |
NCT05298280 -
Vertical Effects in Class II Patients Treated With Distalization
|
N/A | |
Completed |
NCT04556448 -
RCT Comparing Invisalign and Traditional Orthodontic Treatment
|
N/A | |
Completed |
NCT03455634 -
Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
|
N/A |