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

ConditionImplant Stability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-38
SponsorUniversity of Baghdad

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Syndromic conditions, facial trauma, or previous bone-related surgery.

Trial design

Design model

Crossover

Treatments tested in this trial

  • insersion of two diameters of mini implant.

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: 1.6 mmExperimental treatment 1 intervention
Group B: 2 mmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

primary stability

primary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).

Time frame
immediately after insertion
2

secondary stability

secondary stability measurement using easy check device (Dentium, south Korea) giving range of (1 - 100).

Time frame
two month after insertion.

Secondary outcomes

1

pain perception

using Visual Analogue Score (VAS) \[1-10\] higher score means higher pain.

Time frame
after insertion 24 hour, 48 hour, 72 hour.
2

Failure rate

Failure is considered when the mini implant become loose, peri-implant inflammation or fallen after insertion.

Time frame
monthly for six months after insertion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov
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