Study Stopped
Study stopped due to increased harm and slow progress in the intervention group.
A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion
1 other identifier
interventional
64
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2009
CompletedFirst Posted
Study publicly available on registry
August 12, 2009
CompletedMay 16, 2023
May 1, 2023
1.7 years
August 11, 2009
May 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of treatment with functional appliance
9 months
Overjet measurement
9 months
Secondary Outcomes (1)
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
Study Arms (2)
Functional appliance-Dynamax
EXPERIMENTALFunctional appliance- twin block
OTHERConventional treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manchesterlead
- National Health Service, United Kingdomcollaborator
Study Sites (2)
Chesterfield Royal Hospital
Chesterfield, United Kingdom
Derby Royak Hospital NHS Trust
Derby, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 11, 2009
First Posted
August 12, 2009
Study Start
January 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
May 16, 2023
Record last verified: 2023-05