Clinical trial NCT00957489: A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Class II Division 1 Malocclusion
Keywords: Orthodontic treatment of Class II division 1 malocclusion
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2009-08-12
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of treatment with functional appliance
timeFrame: 9 months
measure: Overjet measurement
timeFrame: 9 months
Secondary outcomes:
measure: 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
timeFrame: 9 months
Other outcomes:
Locations:
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital
city: Derby
country: United Kingdom
facility: Derby Royak Hospital NHS Trust
Study officials:
affiliation: Prof of Orthodontics/ Associate Dean Teaching and Learning, University of Manchester
name: Kevin O'Brien, BDS, MSc, FDSRCS, DORth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant Orthodontist, Chesterfield NHS Trust
name: Jonathan Sandler, BDS, MSc, FDSRCS, MOrth RCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant Orthodontist, Derby NHS Trust
name: Alison Murray, BDS, MSc, FDSRCS, MORth RCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Teaching Fellow in Orthodontics, University of Manchester
name: Badri ' Thiruvenkatachari, BDS, MDS, MOrth RCS, PhD
role: STUDY_DIRECTOR
References: