Status:
ACTIVE_NOT_RECRUITING
The Introduction of a Novel PAOO Technique
Lead Sponsor:
Semmelweis University
Collaborating Sponsors:
NSK Europe GmbH
Conditions:
Bone Loss
Tooth Movement
Eligibility:
All Genders
14-60 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate in a prospective, randomized, controlled clinical trail the effectiveness of preorthodontic piezotomy combined with a buccal bone augmentation (in other name perio...
Detailed Description
Patients presenting teeth crowding in mandibulary or maxillary front area, without ongoing periodontal disease, who require OTM with incisor proclination, are included in the study. Patients are rando...
Eligibility Criteria
Inclusion
- tooth crowding exceeding a 5mm lack of space (originating from the discrepancy between the overall mesiodostal length of the teeth and the length of the dental arch present at the time of the evaluation)
- thin bone morphotype (buccal width of the cortical layer must be under 1mm)
- incisor proclination in order to eliminate crowding without compensatory extractions.
- informed consent
Exclusion
- ongoing periodontitis
- Pregnant women.
- Participation in another clinical study within 30 days prior to study start.
- Alcoholism, drug dependency, heavy smoking (\>5 cigarettes/day).
- Known infection with HIV, HBV, or HCV.
- Patients requiring chemo- or radiotherapy.
- Previous or current radiotherapy of the head.
- Uncontrolled or insulin-dependent diabetes mellitus
- Clinically relevant osteoporosis or systemic disease affecting bone metabolism
- Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months.
- Clinically relevant blood coagulation disorder.
- Previous or current treatment with systemic corticosteroids (within 2 months prior to screening visit) of more than 5 mg/day prednisone equivalent.
- Previous or current therapy with bisphosphonates at least for 30 days within the last 12 months before screening visit
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05264480
Start Date
April 1 2019
End Date
July 30 2025
Last Update
January 8 2025
Active Locations (1)
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1
Semmelweis University Department of Periodontology
Budapest, Hungary, 1088