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

Primary Purpose

Class II Division 1 Malocclusion

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dynamax appliance
Twin-block appliance
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Orthodontic treatment of Class II division 1 malocclusion

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chesterfield Royal Hospital
  • Derby Royak Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Functional appliance-Dynamax

Functional appliance- twin block

Arm Description

Conventional treatment

Outcomes

Primary Outcome Measures

Duration of treatment with functional appliance
Overjet measurement

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2009
Last Updated
May 14, 2023
Sponsor
University of Manchester
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00957489
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to increased harm and slow progress in the intervention group.
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
National Health Service, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Orthodontic treatment of Class II division 1 malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional appliance-Dynamax
Arm Type
Experimental
Arm Title
Functional appliance- twin block
Arm Type
Other
Arm Description
Conventional treatment
Intervention Type
Other
Intervention Name(s)
Dynamax appliance
Intervention Type
Other
Intervention Name(s)
Twin-block appliance
Primary Outcome Measure Information:
Title
Duration of treatment with functional appliance
Time Frame
9 months
Title
Overjet measurement
Time Frame
9 months
Secondary Outcome Measure Information:
Title
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin O'Brien, BDS, MSc, FDSRCS, DORth, PhD
Organizational Affiliation
Prof of Orthodontics/ Associate Dean Teaching and Learning, University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Sandler, BDS, MSc, FDSRCS, MOrth RCS
Organizational Affiliation
Consultant Orthodontist, Chesterfield NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alison Murray, BDS, MSc, FDSRCS, MORth RCS
Organizational Affiliation
Consultant Orthodontist, Derby NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Badri ' Thiruvenkatachari, BDS, MDS, MOrth RCS, PhD
Organizational Affiliation
Clinical Teaching Fellow in Orthodontics, University of Manchester
Official's Role
Study Director
Facility Information:
Facility Name
Chesterfield Royal Hospital
City
Chesterfield
Country
United Kingdom
Facility Name
Derby Royak Hospital NHS Trust
City
Derby
Country
United Kingdom

12. IPD Sharing Statement

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

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