RecruitingNot ApplicableNCT07337538

Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.

Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)

Sponsor

University of Baghdad

Enrollment

20 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Implant Stability

Summary

The goal of this clinical trials is to compare two diameters, 1.6 and 2 mm, of mini implants both are 12 mm length placed in the infrazygomatic crest region. The main questions it aims to answer are: which diameter is more suitable for IZC region 1.6 or 2mm in terms of primary stability, secondary stability, pain perception and failure rate. 20 participant will receive 40 mini implant bilaterally (20 in one side of 1.6mm, the other side 20 of 2mm). participants will be asked to record visual analog scale (VAS) for 3 nights monitored monthly by the investigator.

Eligibility

Min Age: 15 YearsMax Age: 38 Years

Inclusion Criteria4

Individuals aged between 15 and 38 years.
Patients currently undergoing orthodontic treatment with fixed appliances who require mini-implant placement in the upper buccal posterior region (IZC) for full-arch distalization or en-masse retraction.
Patients willing and able to adhere to the study protocol.
Recommended for the use of bilateral mini-implants.

Exclusion Criteria1

Syndromic conditions, facial trauma, or previous bone-related surgery.

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Interventions

DEVICEinsersion of two diameters of mini implant.

insertion of the two diameters in the infrazygomatic crest region (IZC) bilaterally (one for each side) then check difference in primary stability, secondary stability, pain perception and failure rate.