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

University of Baghdad

Status: Enrolling

Conditions: Implant Stability

Treatments: Device: insersion of two diameters of mini implant.

Study type: Interventional

Funder types: Other

Identifiers

NCT07337538

1152425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 15 to 38 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

1.6 mm

Experimental group

Description:

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

Treatment:

Device: insersion of two diameters of mini implant.

2 mm

Experimental group

Description:

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

Treatment:

Device: insersion of two diameters of mini implant.