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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Class II Division 1 Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Functional appliance-Dynamax

Group Type EXPERIMENTAL

Dynamax appliance

Intervention Type OTHER

Functional appliance- twin block

Conventional treatment

Group Type OTHER

Twin-block appliance

Intervention Type OTHER

Interventions

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Dynamax appliance

Intervention Type OTHER

Twin-block appliance

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes