NCT Number: NCT07337538
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.
Interested in participating?
Request Info15 year–38 year
All sexes
Interventional
Not applicable
Baghdad university, Baghdad, Baghdad Governorate, Iraq
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: immediately after insertion
primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
Time frame: two month after insertion.
secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
Time frame: after insertion 24 hour, 48 hour, 72 hour.
using Visual Analogue Score (VAS) [1-10] higher score means higher pain.
Time frame: monthly for six months after insertion.
Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion.
Contact information is provided by the study sponsor or research team.
Ali J. Al Ameri, BDS.
CONTACT
Mehdi A. Alrubayee, PHD.
CONTACT
University of Baghdad
Other
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)
Acronym: TADs
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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