NCT07337538

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 15 Years – 38 Years
• Healthy volunteers: Accepted

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.

Detailed description

Using 1.6x12mm and 2x12mm of mini implants in the IZC area and measuring primary stability, secondary stability, failure rate and pain perception. The primary stability will be measured immediately after insertion using Easycheck device (Dentium, South Korea). The secondary stability will be measured two months after insertion using the same device. Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion, it will be checked monthly for six months. pain perception will be recorded by patients using visual analog scale (VAS) score sheet 24 , 48, 72 hour after insertion. Null hypothesis There is no significant difference between 1.6 and 2mm IZC mini implant diameters in terms of primary stability, secondary stability, failure rate and pain perception.

Conditions

• Implant Stability

Interventions

Type	Name	Description
DEVICE	insersion 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.

Timeline

• Start date: 2026-01-14
• Primary completion: 2026-09-01
• Completion: 2026-11-01
• First posted: 2026-01-13
• Last updated: 2026-01-20

Locations

2 sites across 1 country: Iraq