Implant Stability
Conditions
Keywords
temporary anchorage device stability, Tads, mini implant, miniscrew
Brief 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.
Interventions
DEVICEinsersion 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.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
15 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals aged between 15 and 38 years. 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
* Syndromic conditions, facial trauma, or previous bone-related surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary stability | immediately after insertion | primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100). |
| secondary stability | two month after insertion. | secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain perception | after insertion 24 hour, 48 hour, 72 hour. | using Visual Analogue Score (VAS) \[1-10\] higher score means higher pain. |
| Failure rate | monthly for six months after insertion. | Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion. |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORAli J. Al Ameri, BDS.
University of Baghdad
Outcome results
None listed