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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
20
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.
Saydiya dental clinic
Baghdad, Baghdad Governorate, Iraq
NOT_YET_RECRUITINGBaghdad university
Baghdad, Baghdad Governorate, Iraq
RECRUITINGprimary stability
primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
Time frame: immediately after insertion
secondary stability
secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
Time frame: two month after insertion.
pain perception
using Visual Analogue Score (VAS) \[1-10\] higher score means higher pain.
Time frame: after insertion 24 hour, 48 hour, 72 hour.
Failure rate
Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion.
Time frame: monthly for six months after insertion.
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