Comparison of Efficacy of Three Orthodontic Appliances
Comparison of Clinical Efficacy of Three Class II Correctors in Orthodontics, Prospective Expertise Matched Controlled Trial
1 other identifier
interventional
183
0 countries
N/A
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 one modality alone Which of the three orthodontic appliances does achieve best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 1, 2018
February 1, 2018
1.3 years
May 4, 2017
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants who have experienced discomfort related to wearing the appliance
This is to check which appliance produces more discomfort compared to the other appliances using the Likert scale. Each question on the scale asks to rate the pain as either (no pain, slight pain, moderate pain, severe pain) or (strongly disagree, disagree, agree, strongly agree). Patients will choose a response which matches their experience.
18-24 months
establishing which appliance has the fastest completion time
The three appliances will be compared in 'months' from the start of treatment till the completion of treatment to see which is the fastest to achieve the end result
18-24 months
Study Arms (3)
Twin Block
EXPERIMENTAL61 patients will receive the Twin Block appliance (one of the three appliances being studied)
Herbst
ACTIVE COMPARATOR61 patients will receive the Herbst appliance (one of the three appliances being studied)
Frog distalising appliance
ACTIVE COMPARATOR61 patients will receive the Frog distalising appliance (one of the three appliances being studied)
Interventions
To study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk Bister, Consultant
Guy's and St Thomas NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2017
First Posted
March 1, 2018
Study Start
April 1, 2018
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
March 1, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share
No personal patient details will be shared. Only study data collected.