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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00957489 |
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Date of registration:
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11/08/2009 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Date of first enrolment:
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January 2007 |
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Target sample size:
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64 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00957489 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Badri ` Thiruvenkatachari, BDS, MDS, MOrth RCS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Teaching Fellow in Orthodontics, University of Manchester |
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Name:
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Jonathan Sandler, BDS, MSc, FDSRCS, MOrth RCS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Consultant Orthodontist, Chesterfield NHS Trust |
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Name:
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Alison Murray, BDS, MSc, FDSRCS, MORth RCS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Consultant Orthodontist, Derby NHS Trust |
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Name:
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Kevin O'Brien, BDS, MSc, FDSRCS, DORth, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Prof of Orthodontics/ Associate Dean Teaching and Learning, University of Manchester |
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Key inclusion & exclusion 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
Age minimum:
10 Years
Age maximum:
14 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Class Ii Division 1 Malocclusion
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Intervention(s)
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Other: Dynamax appliance
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Other: Twin-block appliance
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Primary Outcome(s)
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Duration of treatment with functional appliance
[Time Frame: Yes]
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Overjet measurement
[Time Frame: Yes]
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Secondary Outcome(s)
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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: Yes]
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Secondary ID(s)
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DTT project
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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