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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.6 mm | Experimental | 1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation. |
|
| 2 mm | Experimental | 2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insersion of two diameters of mini implant. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| primary stability | primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100). | immediately after insertion |
| secondary stability | secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100). | two month after insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| pain perception | using Visual Analogue Score (VAS) [1-10] higher score means higher pain. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali J. Al Ameri, BDS. | Contact | +9647775039229 | Ali.Fahd2403@codental.uobaghdad.edu.iq | |
| Mehdi A. Alrubayee, PHD. | Contact | +9647703909151 | mehdi.a.151@codental.uobaghdad.edu.iq |
| Name | Affiliation | Role |
|---|---|---|
| Ali J. Al Ameri, BDS. | University of Baghdad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saydiya dental clinic | Not yet recruiting | Baghdad | Baghdad Governorate | 10017 | Iraq |
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| ID | Term |
|---|---|
| C536919 | Tietz syndrome |
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20 participants will be enrolled. Each participant will receive two interventions concurrently, with a 1.6-mm diameter mini-implant placed on one infra-zygomatic crest and a 2.0-mm diameter mini-implant placed on the contralateral side. The side allocation of implant diameter will be randomized in an alternating manner (left-right).
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Participants will be blinded to the diameter of the mini-implants placed on each side. The investigator performing the insertion will not be blinded due to the obvious difference in implant diameter.
| monthly for six months after insertion. |
| Baghdad university | Recruiting | Baghdad | Baghdad Governorate | 10047 | Iraq |
|