Actively Recruiting
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)
Led by University of Baghdad · Updated on 2026-01-20
20
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two different diameters, 1.6 mm and 2 mm, of mini implants both 12 mm in length, placed in the infrazygomatic crest (IZC) region. The study focuses on determining which diameter is more suitable in terms of primary stability, secondary stability, pain perception, and failure rate. Twenty participants will each receive 40 mini implants bilaterally, with 20 implants of each diameter distributed on either side of the face. The intervention involves inserting the two different mini implant diameters in the IZC region on opposite sides of each participant's mouth according to a split-mouth randomized design. Primary stability will be measured immediately after insertion using the Easycheck device, while secondary stability will be assessed two months later with the same device. Pain perception will be recorded by participants using a visual analog scale (VAS) for three nights post-insertion, and failure rates will be monitored monthly for six months. Participants will be asked to record their pain levels for 24, 48, and 72 hours after the implant insertion. Monthly assessments will check for implant loosening, inflammation, or loss over six months. The study measures primary and secondary stability as primary outcomes, with pain perception and failure rates as secondary outcomes. The total monitoring period allows thorough evaluation of implant performance and patient experience.
CONDITIONS
Brief Title
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (infrazygomatic crest) 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.
You will not qualify if you...
- Syndromic conditions.
- Facial trauma.
- Previous bone-related surgery.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive insertion of two mini-implants of different diameters in the infrazygomatic crest region, one on each side as per split-mouth allocation.
1 visit (in-person) for implant insertion and primary stability measurement
Duration - 6 months
Participants record pain perception using a visual analog scale at 24, 48, and 72 hours after insertion, and attend visits for monthly checks for six months to monitor implant stability and failure.
1 visit at 2 months for secondary stability measurement and monthly visits for up to 6 months for failure monitoring
Trial Site Locations
Total: 2 locations
1
Saydiya dental clinic
Baghdad, Baghdad Governorate, Iraq, 10017
Not Yet Recruiting
2
Baghdad university
Baghdad, Baghdad Governorate, Iraq, 10047
Actively Recruiting
Research Team
A
Ali J. Al Ameri, BDS.
M
Mehdi A. Alrubayee, PHD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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