Clinical Trial: A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title:
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: University of Manchester
Current Primary Outcome:
- Duration of treatment with functional appliance
- Overjet measurement
Original Primary Outcome: Same as current
Current Secondary Outcome: 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
Original Secondary Outcome: Same as current
Information By: University of Manchester
Dates:
Date Received: August 11, 2009
Date Started: January 2007
Date Completion:
Last Updated: August 11, 2009
Last Verified: August 2009
