Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: insersion of two diameters of mini implant..
- Who it may be relevant to
- Registry conditions: Implant Stability. Basic parameters: 15 years — 38 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)
Overview
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
- Device 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.
Primary outcome measures
- primary stability [Time frame: immediately after insertion]
- secondary stability [Time frame: two month after insertion.]
Secondary outcome measures (2)
- pain perception [Time frame: after insertion 24 hour, 48 hour, 72 hour.]
- Failure rate [Time frame: monthly for six months after insertion.]
Eligibility criteria
Inclusion criteria
- Individuals aged between 15 and 38 years.
- 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.
- Patients willing and able to adhere to the study protocol.
- Recommended for the use of bilateral mini-implants.
Exclusion criteria
- Syndromic conditions, facial trauma, or previous bone-related surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Device feasibility
Study locations
Iraq · 2 centers
- Saydiya dental clinic — Baghdad
- Baghdad university — Baghdad
Identifiers
NCT: NCT07337538 · 1152425