A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion

This study has been terminated.
(Study stopped due to increased harm and slow progress in the intervention group.)
Sponsor:
Collaborators:
UoM
National Health Service, United Kingdom
Information provided by:
University of Manchester
ClinicalTrials.gov Identifier:
NCT00957489
First received: August 11, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 11, 2009
August 11, 2009
January 2007
September 2008   (final data collection date for primary outcome measure)
  • Duration of treatment with functional appliance [ Designated as safety issue: Yes ]
  • Overjet measurement [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Harms Breakages Number of treatment visits Total treatment time Quality of occlusal result (PAR Index) Restricted cephalometric (radiograph) analysis Patient perception questionnaire at six months into treatment [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion
Not Provided

Twin-Block treatment and Dynamax treatment for Class II division 1 malocclusion do not have different effects with regards to treatment duration, the quality of dento-occlusal outcome, skeletal and soft tissue profile, patient discomfort and gingival health.

The Dynamax appliance is a relatively new appliance for the treatment of Class II malocclusion and was introduced in 2003. The appliance has the theoretical advantages of incremental mandibular advancement without the need for bite registration, and the ability for the operator to simultaneously provide the functional and fixed appliance phases of treatment. Furthermore, the Dynamax appliance is designed to limit lower both lower incisor proclination and upper incisor retroclination without an increase in lower facial height. There has been limited research into this appliance and only one trial has been carried out. In this study the effects of the Dynamax were compared with the Twin-block, unfortunately, the trial was not carried out to contemporary standards and suffered from severe shortcomings. For example, the non compliance rate was not accounted for in the sample size calculation, the randomisation sequence was not clear, the investigators did not carry out an intention-to-treat analysis, the statistical analysis was simplistic and the study was carried out in a single dental school setting. This raises the question about the efficiency of the Dynamax appliance and whether or not they are effective in a 'real' world setting.

The aim of this study is to compare the effectiveness of the Dynamax appliance and the Twin-block appliance for the treatment of Class II Division 1 malocclusion.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Class Ii Division 1 Malocclusion
  • Other: Dynamax appliance
  • Other: Twin-block appliance
Experimental: Functional appliance
Interventions:
  • Other: Dynamax appliance
  • Other: Twin-block appliance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a Class II malocclusion as defined by British Standards Institute classification.
  • Overjet greater than 6mm
  • Aged 10-14 years
  • Clinical examination indicates a functional appliance is not contraindicated

Exclusion Criteria:

  • Orthognathic treatment is required or there is a strong indication it will be required in the future
  • Possession of a craniofacial anomaly
  • Previous orthodontic treatment and/or premolar extraction
  • Hypodontia of more than one teeth in any quadrant excluding third molars
  • Inadequate oral hygiene
Both
10 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00957489
DTT project
Yes
Kevin O'Brien, University of Manchester
University of Manchester
  • UoM
  • National Health Service, United Kingdom
Principal Investigator: Kevin O'Brien, BDS, MSc, FDSRCS, DORth, PhD Prof of Orthodontics/ Associate Dean Teaching and Learning, University of Manchester
Principal Investigator: Jonathan Sandler, BDS, MSc, FDSRCS, MOrth RCS Consultant Orthodontist, Chesterfield NHS Trust
Principal Investigator: Alison Murray, BDS, MSc, FDSRCS, MORth RCS Consultant Orthodontist, Derby NHS Trust
Study Director: Badri ` Thiruvenkatachari, BDS, MDS, MOrth RCS, PhD Clinical Teaching Fellow in Orthodontics, University of Manchester
University of Manchester
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP