Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
NCT ID: NCT07337538
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2026-01-14
2026-11-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
SINGLE
Study Groups
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1.6 mm
1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.
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.
2 mm
2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Patients willing and able to adhere to the study protocol.
4. Recommended for the use of bilateral mini-implants.
Exclusion Criteria
15 Years
38 Years
ALL
Yes
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Ali Jabbar Al Ameri
student researcher
Principal Investigators
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Ali J. Al Ameri, BDS.
Role: PRINCIPAL_INVESTIGATOR
University of Baghdad
Locations
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Saydiya dental clinic
Baghdad, Baghdad Governorate, Iraq
Baghdad university
Baghdad, Baghdad Governorate, Iraq
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1152425
Identifier Type: -
Identifier Source: org_study_id
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