Clinical trial NCT05898724: Assessment of the Rate of Oseointegration Surrounding Nano-coated Orthodontic Titanium Miniscrew
Official title: Assessment of the Rate of Oseointegration Surrounding Nano-coated Orthodontic Titanium Miniscrew
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Utilization
Diet, Healthy
Frey Syndrome
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 18
Sex: MALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study will include 18 Egyptian males orthodontic patients divided into three groups; blank group, silver hydroxyapatite group, zinc oxide group. Each group will include six patients that will have a surgical procedure to install two orthodontic miniscrews (blank or nano-coated) (1.6 mm diameter and 6 mm length).
Primary purpose: TREATMENT

Brief summary: The current study was directed to evaluate rate of oseointegration surrounding nano-coated orthodontic titanium miniscrew.The current study will conduct on eighteen Egyptian males orthodontic patients for three months.

Study Groups:

A- Blank group: include six orthodontic patients, which have a surgical procedure to install two orthodontic titanium miniscrews in the two lateral parts of the maxilla , so this group will include 12 installed orthodontic titanium miniscrews.

B- Silver hydroxyapatite group: include six orthodontic patients, which have a surgical procedure to install two silver hydroxyapatite nano-coated orthodontic titanium miniscrews in the two lateral parts of the maxilla, so this group will include 12 installed silver hydroxyapatite nano-coated orthodontic titanium miniscrews.

C- Zinc oxide group: include six orthodontic patients, which have a surgical procedure to install two zinc oxide nano-coated orthodontic titanium miniscrews in the two lateral parts of the maxilla, so this group will include 12 installed zinc oxide nano-coated orthodontic titanium miniscrews.

Detailed description: The present study will include 18 Egyptian males orthodontic patients divided into three groups; blank group, silver hydroxyapatite group, zinc oxide group. Each group will include six orthodontic patients that will have a surgical procedure to install two orthodontic miniscrews (blank or nano-coated) (1.6 mm diameter and 6 mm length). The Surgical procedure in all groups will performed by the same operator.

Before installation of the orthodontic miniscrews, each participant should have local anesthesia . The two orthodontic miniscrews will install in the two lateral parts of anterior maxilla; one in the right side and another in the left side. The orthodontic miniscrews (The Tomas® orthodontic mini-screws will purchase from Dentaurum Company (Germany) and will be placed by specific driver perpendicular on the installed surface (90 degree).

The head of the orthodontic miniscrews that will use in the current study (blank or nano-coated) will be coated by 3 mm dental composite resin (Z fill, 3M ESPE, St. Paul, MN, USA) to prevent transferring of any heat to the tissues that surround the orthodontic miniscrew and so this may affect the partial oseointegration and stability of the orthodontic miniscrews.

Assessment of quality and quantity of oseointegration.

For assessment of quality and quantity of oseointegration, each orthodontic patient have a CBCT (Cone beam computed tomography) that will take by using Planmeca Romexis MD 3D Extraoral Imaging System. CBCT datasets were acquired by software with reconstruction slice thickness of 0.2 mm and 728 X 728 matrix. The CBCT was made by high resolution scan that was made with isotropic voxel size set at 200mm and 10 X 15 cm field of view. The raw images were exported into Digital Imaging and Communications in Medicine (DICOM). All landmark identifications and measurements were made using Planmeca Romexis Viewer 4.4.2.R 3D Imaging Software. The CBCT will be taken just after installation of the orthodontic miniscrews and after three months of installation.

Eligibility criteria: Inclusion Criteria:

1. Health Care Utilization.
2. Daily high calcium meals.
3. free from any systemic diseases.
4. Oral cavity is free from any injury or ulcers

Exclusion Criteria:

1. systemic diseases.
2. fracture of the jaw.
3. injuries or ulcers within the oral cavity

Primary outcomes:
measure: assessment of quality of oseointegration
timeFrame: three months
Secondary outcomes:
measure: Microbial interaction
timeFrame: three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nasr city
Study officials:
affiliation: Lecturer of orthodontics - Faculty of dental medicine - Al-Azhar university
name: Mahmoud MF Abo - Elmahasen, PHD
role: PRINCIPAL_INVESTIGATOR
References: