Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293872
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2024-02-27
Brief Title:
Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region
Sponsor:
University of Baghdad
Organization:
University of Baghdad
Study Overview
Official Title:
Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region A Randomized Clinical Trial Split-mouth Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability pain perception sinus penetration secondary stability and failure rate
Detailed Description:
orthodontic mini-implants also known as miniscrew implants or temporary anchorage devices offer an effective panacea for Anchorage loss problem during fixed appliance treatments
Indeed Mini-implant implantation has become an essential method of controlling anchorage in the clinic and plays an important role in solving some difficult cases where the integration of orthodontic mini-implants within fixed appliance treatments offers other advantages over conventional anchorage
Intra-radicular micro-implants are placed in between the roots of teeth mostly while extra-radicular bone screws are placed away from the roots in the infra-zygomatic areas IZC of the maxilla and the buccal shelf areas BS of the mandible Both extra-radicular bone screws and intra-radicular are classified under temporary anchorage devices used for the purpose of skeletal anchorage
Due to the limited space there is a risk of injury to the roots while using Intra-radicular micro-implants Therefore the infrazygomatic crest zone is selected as an alternative implantation site in the clinic The infrazygomatic crest has a double-layered cortex and is close to the maxillary center of the resistance which is suitable for implantation and provides strong anchorage
Orthodontic bone screws can be used in almost every clinical situation that a micro-implant is used for except that they cannot be placed inter-dental purely because of their larger dimension They can be used for molar uprighting segmental and full arch distalization intrusion of single tooth to full arch protraction and retraction of dentition and for any other anchorage needs
the two most specific indications would be - full arch distalization of maxillary and mandibular dentition to camouflage a Class II and a Class III malocclusion and for distalization of arches in re-treatment cases of anchorage loss which are otherwise difficult to be done with a regular micro-implant or time-consuming
However it is adjacent to the maxillary sinus and tooth roots therefore we have to consider many factors such as bone mass the thickness of the buccal cortex and the relationship with the maxillary sinus and roots before implantation in the infrazygomatic crest Furthermore previous research by our research group found that it is safe to penetrate the maxillary sinus within 1 mm
This study will be conducted to test the feasibility reliability of using two different sizes of infrazygomatic mini-implant regarding primary stability pain perception sinus penetration secondary stability and failure rate
Indeed Mini-implant implantation has become an essential method of controlling anchorage in the clinic and plays an important role in solving some difficult cases where the integration of orthodontic mini-implants within fixed appliance treatments offers other advantages over conventional anchorage
Intra-radicular micro-implants are placed in between the roots of teeth mostly while extra-radicular bone screws are placed away from the roots in the infra-zygomatic areas IZC of the maxilla and the buccal shelf areas BS of the mandible Both extra-radicular bone screws and intra-radicular are classified under temporary anchorage devices used for the purpose of skeletal anchorage
Due to the limited space there is a risk of injury to the roots while using Intra-radicular micro-implants Therefore the infrazygomatic crest zone is selected as an alternative implantation site in the clinic The infrazygomatic crest has a double-layered cortex and is close to the maxillary center of the resistance which is suitable for implantation and provides strong anchorage
Orthodontic bone screws can be used in almost every clinical situation that a micro-implant is used for except that they cannot be placed inter-dental purely because of their larger dimension They can be used for molar uprighting segmental and full arch distalization intrusion of single tooth to full arch protraction and retraction of dentition and for any other anchorage needs
the two most specific indications would be - full arch distalization of maxillary and mandibular dentition to camouflage a Class II and a Class III malocclusion and for distalization of arches in re-treatment cases of anchorage loss which are otherwise difficult to be done with a regular micro-implant or time-consuming
However it is adjacent to the maxillary sinus and tooth roots therefore we have to consider many factors such as bone mass the thickness of the buccal cortex and the relationship with the maxillary sinus and roots before implantation in the infrazygomatic crest Furthermore previous research by our research group found that it is safe to penetrate the maxillary sinus within 1 mm
This study will be conducted to test the feasibility reliability of using two different sizes of infrazygomatic mini-implant regarding primary stability pain perception sinus penetration secondary stability and failure rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None