Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.

NCT ID: NCT07337538

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-14

Study Completion Date

2026-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Implant Stability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1.6 mm

1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.

Group Type EXPERIMENTAL

insersion of two diameters of mini implant.

Intervention Type 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.

2 mm

2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.

Group Type EXPERIMENTAL

insersion of two diameters of mini implant.

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ali Jabbar Al Ameri

student researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ali J. Al Ameri, BDS.

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saydiya dental clinic

Baghdad, Baghdad Governorate, Iraq

Site Status NOT_YET_RECRUITING

Baghdad university

Baghdad, Baghdad Governorate, Iraq

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iraq

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ali J. Al Ameri, BDS.

Role: CONTACT

+9647775039229

Mehdi A. Alrubayee, PHD.

Role: CONTACT

+9647703909151

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ali J. Al Ameri, BDS

Role: primary

+9647775039229

Mehdi A. Alrubayee, PHD.

Role: primary

+9647703909151

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1152425

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.