Assessment of the Rate of Oseointegration Surrounding Nano-coated Orthodontic Titanium Miniscrew

Diet, Healthy Clinical Trial

Official title:

Assessment of the Rate of Oseointegration Surrounding Nano-coated Orthodontic Titanium Miniscrew

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05898724
• Other study ID #: 915/307
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: Al-Azhar University
• Contact: Mahmoud MF Abo - Elmahasen, PHD
• Phone: 01025300767
• Email: MahmoudFathy.209[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Health Care Utilization

Intervention

Procedure:
• 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 of each patient, so this group will include 12 installed orthodontic titanium miniscrews.
• Silver hydroxyapatite
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 of each patient, so this group will include 12 installed silver hydroxyapatite nano-coated orthodontic titanium miniscrews.
• Zinc oxide
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 of each patient, so this group will include 12 installed zinc oxide nano-coated orthodontic titanium miniscrews.

Locations

Country	Name	City	State
Egypt	Nasr city	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of quality of oseointegration	each 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.	three months
Secondary	Microbial interaction	by taking 18 swabs from oral cavity surround each orthodontic mini-screw (blank, silver hydroxyapatite, zinc oxide), after that the swab is analysed to assess the microbial action against normal flora of the oral cavity of the the orthodontic patients.	three months