Miniscrews Primary Stability
Sponsor:
University of Genova
Collaborators:
Information provided by (Responsible Party):
Marco Migliorati，University of Genova
| Tracking Information | |||
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| First Submitted Date ICMJE | July 18, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | September 29, 2018 | ||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Success[ Time Frame: From the moment the screw will be placed, measuring maximum insertion torque, through study completion, when the screws will be removed, measuring removal torque. An average duration of screw of 10-12 months is expected. ] How many screws don't fail. Success if the screw remain stable until the end of biomechanics applied. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Miniscrews Primary Stability |
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| Official Title ICMJE | Multicentric Clinical Study Protocol on Primary Stability of STORM® Miniscrew |
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| Brief Summary | Orthodontic Miniscrew primary stability is essential for success and long term results. The aim of the present study is to evaluate Bone Properties and Torque insertion values and how they could be related to primary stability and success rate of miniscrew. |
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| Detailed Description | Orthodontic miniscrews are intraoral anchorage devices designed to support biomechanics during orthodontic tooth movement. Also known as miniscrews, mini-implants, microscrews, or temporary anchorage devices, they are made of a head, a neck, and a threaded shank. The head may show different designs (bracket-like, rounded with slot, etc.) the threaded shank is generally cylindrical, tapered or a combination of the two, and may be self-tapping (i.e. requiring a pre-drilled pilot hole) and/or self-drilling (not requiring a pilot hole). Because of their small diameter, they may be implanted in a wide variety of anatomic sites, such as the alveolar interradicular spaces or the palatal cortical bone, in order to attend to treatment anchorage needs. The loading protocol for miniscrews loading can be as immediate as delayed; in the beginning in literature was indicated a non-specific period of healing and osseointegration before a screw inserted in the mandible could be loaded; the importance of a healing period was derived by several studies on Branemark protocol on implants. Further experimental studies on orthodontic load were not able to demonstrate loaded implant loosening, even when loads were applied immediately, so that an immediate loading protocol for orthodontic miniscrews appeared as reasonable. Costa and Melsen studied the tissue reaction around the immediately loaded screws in an animal model and suggested the use of immediately loaded screws as an intra-oral extra-dental anchorage. Histomorphometric analyses have shown that the immediate loading of miniscrew implants may help to activate bone remodeling and increase the mineral contents at the loaded region. Compared to traditional endosseous implants, orthodontic miniscrews have relatively high failure rates, varying from 16.4% to 39% ; according to recent reviews, the average failure rate is believed to be less than 20%. Many factors have been proposed to be associated to success rate; among these age, gender, jaw (maxilla or mandible), placement site, tissue mobility (firm or movable tissue), inflammation, distance to the root, insertion torque, loading time, type, length, and diameter of the miniscrew. Recently, an experimental study on primary stability found that bone properties are more important than the screw geometry in establishing primary mechanical retention. Thus the aim of this study is to deeply analyze the bone role related to the success of miniscrews analyzing both insertion/removal torque values, both bone characteristics by the mean of x-rays. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description:data sheet will be blinded for the analyses Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Active, not recruiting | ||
| Estimated Enrollment ICMJE |
30 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 30, 2019 | ||
| Estimated Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - patient who need ortho treatment with miniscrew - permanent dentition Exclusion Criteria: - bone pathologies - systemic disease | ||
| Sex/Gender |
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| Ages | 12 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Italy|Spain | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Marco Migliorati，University of Genova | ||
| Study Sponsor ICMJE | University of Genova | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of Genova | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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