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

Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region (A Randomized Clinical Trial, Split-mouth Study)

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

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Device: 12*2 mm length miniscrew

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10011
    • University of Baghdad College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12*2 mm length miniscrew; 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.	Device: 12*2 mm length miniscrew; Prior to mini-inplant insertion the patient will instructed to rinse mouth with chlorhexidine mouthwash, then local anesthesia will be applied. The clinical implication for miniscrew insertion in the IZ crest of adults is 14 to 16 mm above the maxillary occlusal plane and the maxillary first molar. 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; Other Names: 14*2 mm length miniscrew
Active Comparator: 14*2 mm length miniscrew; 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.	Device: 12*2 mm length miniscrew; Prior to mini-inplant insertion the patient will instructed to rinse mouth with chlorhexidine mouthwash, then local anesthesia will be applied. The clinical implication for miniscrew insertion in the IZ crest of adults is 14 to 16 mm above the maxillary occlusal plane and the maxillary first molar. 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; Other Names: 14*2 mm length miniscrew

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
failure rate	the miniscrew regarded as failed if it is mobile and can not fulfill it is anchorage function, covered by soft tissue.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary stability	primary stability measured for each patient immediately after placemat with use of Dentium stability measuring system (EasyCheck).	immediately after placement
secondary stability	secondary stability measured for each patient immediately after placemat with use of Dentium stability measuring system (EasyCheck).	after 6months
pain perception	Patients asked to record any pain experienced on the visual analog scale (VAS) score.	after 1st day and after 1st week

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: Mehdi abd Alrubayee, B.D.S; M.Sc; PhD, Assistant Professor, Department of Orthodontics, College of Dentistry, University of Baghdad, Iraq.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mini-screws, infrazygomatic crest zone, IZC, orthodontics implant.
• Other Study ID Numbers: IZC miniscrew

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 10/10/2024 for 3 months
• IPD Sharing Access Criteria: I can provide data as word
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No