Status:
UNKNOWN
Comparison of Efficacy of Three Orthodontic Appliances
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Malocclusion, Angle Class II
Eligibility:
All Genders
10-16 years
Phase:
NA
Brief Summary
To investigate each treatment modality in its "optimal" environment to avoid operator experience bias. Therefore we propose to operate out of three "specialist centres" with specific units providing o...
Detailed Description
Patients and materials: The patient population will consist of patients age 10-16 that have, or are close to having, a full permanent dentition, and present to the clinic with Class II malocclusions w...
Eligibility Criteria
Inclusion
- Patients aged 10-16 years of age in the late mixed/permanent dentition with Class II malocclusions (Both Cl II div 1 and Cl II div 2)
- \> 1/2 unit Class II molar relationship bilaterally (at least 3.5mm)
- Normal or deep overbite cases will be included
- Skeletal Class II relationship (ANB \> 4°)
- Overjet ≥ 5 mm in Cl II/1 cases
- Non-extraction cases
Exclusion
- Children in the early mixed dentition
- Class I and Class III malocclusions
- Malocclusions with less than 1/2 unit II molar relationship
- Reduced overbite / anterior openbite
- Medically compromised patients, syndromic patients or patients with severe facial asymmetry
- Special needs patients not able to comply with instructions / difficulty with compliance
- Hypodontia or extracted permanent tooth (except third molars)
- Poor oral hygiene with both Gingival bleeding Index and Plaque Index scoring no more than 1
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT03450551
Start Date
April 1 2018
End Date
August 1 2019
Last Update
March 1 2018
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