Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region

University of Baghdad

Status: Completed

Conditions: Orthodontic Appliance Complication

Treatments: Device: 12*2 mm length miniscrew

Study type: Interventional

Funder types: Other

Identifiers

NCT06293872

IZC miniscrew

Details and patient eligibility

About

Evaluation of two different lengths of mini-implants in the infrazygomatic area regarding primary stability, pain perception, sinus penetration, secondary stability and failure rate.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a. Patients (age of patients is 15-50 y.) need metal fixed orthodontic treatment including placement of miniscrews.

b. The position of mini-implant in upper buccal posterior area (infrazygomatic area).

Exclusion criteria

• • If c.b.c.t show that the screw placed intraradicular will be excluded.

  • Patient choose to discontinue the treatment was regarded as dropout, since this study pre protocol analysis. exclusion criteria, such as images suggesting
  • Images suggesting sinus inflammation or pathology before mini-implant insertin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

12*2 mm length miniscrew

Experimental group

Description:

The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots.

Treatment:

Device: 12*2 mm length miniscrew

14*2 mm length miniscrew

Active Comparator group

Description:

The self-drilling screw is directed at 90° to the occlusal plane at this point. After the initial notch in the bone is created after couple of turns to the driver, the bone screw driver direction is changed by 55°-70° toward the tooth, downward, which aid in bypassing the roots of the teeth and directing the screw to the infra-zygomatic area of the maxilla. The bone screw is screwed until only the head of the screw is visible outside the alveolar mucosa. Follow-up: C.B.C.T will be performed after surgery to verify the implant position relative to the adjacent roots.

Treatment:

Device: 12*2 mm length miniscrew