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

January 15, 2026 updated by: Ali Jabbar Al Ameri, University of Baghdad

Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region (Split-mouth Randomized Clinical Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iraq
    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, Iraq, 10017
        • Not yet recruiting
        • Saydiya dental clinic
        • Contact:
        • Principal Investigator:
          • Ali J. Al Ameri, BDS.
      • Baghdad, Baghdad Governorate, Iraq, 10047
        • Recruiting
        • Baghdad University
        • Contact:
        • Principal Investigator:
          • Ali J. Al Ameri, BDS.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1.6 mm
1.6 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.
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.
Experimental: 2 mm
2 x12 mm mini implant inserted in the infrazygomatic crest region according to split mouth allocation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary stability
Time Frame: immediately after insertion
primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
immediately after insertion
secondary stability
Time Frame: two month after insertion.
secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).
two month after insertion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate
Time Frame: monthly for six months after insertion.
Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion.
monthly for six months after insertion.
pain perception
Time Frame: after insertion 24 hour, 48 hour, 72 hour.
using Visual Analogue Score (VAS) [1-10] higher score means higher pain.
after insertion 24 hour, 48 hour, 72 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: Ali J. Al Ameri, BDS., University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 1, 2026

First Posted (Estimated)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1152425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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