Comparing 1.6 mm versus 2 mm mini-implants in the infra-zygomatic crest
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)
This test compares 1.6 mm and 2 mm (both 12 mm long) mini-implants placed in the infra-zygomatic crest to see which gives better stability, less pain, and fewer failures for people needing orthodontic anchorage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 15 Years to 38 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Locations | 2 sites (Baghdad, Baghdad Governorate and 1 other locations) |
| Trial ID | NCT07337538 on ClinicalTrials.gov |
What this trial studies
This is a within-patient, bilateral comparison in which 20 participants receive two mini-implants each (one 1.6×12 mm and one 2×12 mm) in the infra-zygomatic crest (IZC). Primary stability is measured immediately after insertion with an Easycheck device, and secondary stability is measured again at two months. Patients record pain using a visual analog scale at 24, 48, and 72 hours, and implants are checked monthly for up to six months for signs of failure or inflammation. The trial compares primary and secondary stability, pain scores, and failure rates between the two diameters.
Who should consider this trial
Good fit: Ideal candidates are people aged 15 to 38 who are undergoing orthodontic treatment with fixed appliances and require bilateral IZC mini-implants for full-arch distalization or en-masse retraction and can follow the study visits.
Not a fit: Patients with syndromic conditions, prior facial bone trauma or bone-related surgery, or those who do not require IZC mini-implants are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the trial could identify which implant diameter provides stronger anchorage with less pain and fewer failures, helping clinicians choose the better option for IZC placement.
How similar studies have performed: Similar research on miniscrew diameter and stability exists with mixed results, so the approach is not entirely novel but adds specific data for the IZC site.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baghdad, Baghdad Governorate and 1 other locations
- Saydiya dental clinic — Baghdad, Baghdad Governorate, Iraq (Not_yet_recruiting)
- Baghdad university — Baghdad, Baghdad Governorate, Iraq (Recruiting)
Study contacts
- Principal investigator: Ali J. Al Ameri, BDS. — University of Baghdad
- Study coordinator: Ali J. Al Ameri, BDS.
- Email: Ali.Fahd2403@codental.uobaghdad.edu.iq
- Phone: +9647775039229
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.