Study to Compare Two Functional Appliances for Class II Malocclusions

NCT03773783 | Unknown DMC

• 1 other identifier: RG_16-204
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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). Null hypothesis: There is no significant difference between the Button \& bead and Twin-block appliances with regard to time taken to reduce the overjet

Conditions

Malocclusion, Angle Class II

Keywords

Myofunctional appliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Peer Assessment Rating (PAR)

  PAR score will be Assessed from the start of treatment models and the end of fixed appliance study models ( 2 years later)

• Drop out

  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

  Cephalometric x-rays at start of treatment and at the end of treatment 1 year later

• 3D soft tissue measures

  3D photographs at start of treatment and at the end of treatment (approx 1 year later)

• Patient satisfaction

  Patient satisfaction survey at study completion ( 1 year after treament started)

Study Arms (2)

Twin Block

ACTIVE COMPARATOR

Twin Block appliance

Device: Twin Block appliance

Button and Bead

EXPERIMENTAL

Button and Bead appliance

Device: Button and Bead appliance

Interventions

Button and Bead appliance DEVICE

Button and Bead appliance

Button and Bead

Twin Block appliance DEVICE

Twin Block appliance

Twin Block

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \* 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

You may not qualify if:

• \* 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.

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Birmingham dental hospital

Birmingham, United Kingdom

RECRUITING

Related Publications (11)

• Isaacson KG, Reed RT, Stephens CD. Functional orthodontic appliances. Oxford: Blackwell Scientific Publications; 1990.

  BACKGROUND

• 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.

  PMID: 9457020 BACKGROUND

• 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. doi: 10.1016/S0889-5406(98)70275-6.

  PMID: 9457018 BACKGROUND

• 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. doi: 10.1016/s0889-5406(98)70276-8.

  PMID: 9457019 BACKGROUND

• 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. doi: 10.1016/s0889-5406(03)00345-7.

  PMID: 12923506 BACKGROUND

• 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. doi: 10.1016/S0889540603003524.

  PMID: 12970656 BACKGROUND

• 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.

  PMID: 19409339 BACKGROUND

• Nelson 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.

  PMID: 8338068 BACKGROUND

• 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. doi: 10.1093/ejo/20.5.501.

  PMID: 9825553 BACKGROUND

• 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.

  PMID: 20691354 BACKGROUND

• 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.

  PMID: 10478026 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Thomas Dietrich

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheena Kotecha, FDS MPhil

CONTACT

(+44)07940544164; drkotecha@gmail.com

Thomas Dietrich

CONTACT

T.Dietrich@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: December 12, 2018
• Study Start: July 10, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)