Clinical trial NCT06293872: Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region
Official title: Evaluation of Two Mini-Implant Lengths in the Infra-Zygomatic Crest Region (A Randomized Clinical Trial, Split-mouth Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: mini-screws, infrazygomatic crest zone, IZC, orthodontics implant.
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: failure rate
timeFrame: 6 months
Secondary outcomes:
measure: primary stability
timeFrame: immediately after placement
measure: secondary stability
timeFrame: after 6months
measure: pain perception
timeFrame: after 1st day and after 1st week
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad College of Dentistry
Study officials:
affiliation: Assistant Professor, Department of Orthodontics, College of Dentistry, University of Baghdad, Iraq.
name: Mehdi abd Alrubayee, B.D.S; M.Sc; PhD
role: STUDY_DIRECTOR
References: