Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
1 other identifier
interventional
20
1 country
1
Brief Summary
The trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance, based on "High-Tech" technology. The appliance should be wear only 12-14 hours a day, and is made of a single silicone aligner, made specifically for the patient, using 3-D screening technology of the patient's malocclusion. The aligner has a designed pathway "built-in" for the tooth to move, from the original position of the malocclusion to the "end point" - the correct position. The force system, that is needed in order to generate tooth movement, is produced by tiny air-balloons which are incorporated in the aligner. The study hypothesis is, that an orthodontic treatment can be done successfully with this part-time wearing appliance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
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
June 12, 2007
CompletedFirst Posted
Study publicly available on registry
June 13, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedJune 13, 2007
June 1, 2007
June 12, 2007
June 12, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
study models
every 2 appointments (8 weeks)
Secondary Outcomes (1)
occlusal photographs
every 3 appointments (12 weeks)
Interventions
Eligibility Criteria
You may qualify if:
- mild to moderate class I malocclusion
- good general health
- good oral hygiene
You may not qualify if:
- bad cooperation
- any mental or health problem
- severe class I malocclusion, class II or class III malocclusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meir Redlich
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 12, 2007
First Posted
June 13, 2007
Study Start
December 1, 2007
Last Updated
June 13, 2007
Record last verified: 2007-06