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

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.

Study Overview

• Status: Terminated
• Conditions: Class II Division 1 Malocclusion
• Intervention / Treatment: Other: Dynamax appliance; Other: Twin-block appliance

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Chesterfield, United Kingdom
    • Chesterfield Royal Hospital
  • Derby, United Kingdom
    • Derby Royak Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional appliance-Dynamax	Other: Dynamax appliance
Other: Functional appliance- twin block; Conventional treatment	Other: Twin-block appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of treatment with functional appliance	9 months
Overjet measurement	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	9 months

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: National Health Service, United Kingdom
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 11, 2009
• First Posted (Estimate): August 12, 2009

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Orthodontic treatment of Class II division 1 malocclusion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II
• Other Study ID Numbers: DTT project