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

• Sponsor: Al-Azhar University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05898724
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Care Utilization; Diet, Healthy; Frey Syndrome	Procedure: Blank group; Procedure: Silver hydroxyapatite; Procedure: Zinc oxide	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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).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).
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Assessment of the Rate of Oseointegration Surrounding Nano-coated Orthodontic Titanium Miniscrew
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blank group 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.	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.
Experimental: Silver hydroxyapatite group: 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 of each patient, so this group will include 12 installed silver hydroxyapatite nano-coated orthodontic titanium miniscrews.	Procedure: 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.
Experimental: Zinc oxide group 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 of each patient, so this group will include 12 installed zinc oxide nano-coated orthodontic titanium miniscrews.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. assessment of quality of oseointegration [three months]

   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.

Secondary Outcome Measures

1. Microbial interaction [three months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 20 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nasr city	Cairo		Egypt	11311

Sponsors and Collaborators

• Al-Azhar University

Investigators

• Principal Investigator: Mahmoud MF Abo - Elmahasen, PHD, Lecturer of orthodontics - Faculty of dental medicine - Al-Azhar university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahmoud M. Fathy Aboelmahasen, Lecture of orthodontics - Faculty of dental medicine, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05898724
• Other Study ID Numbers: 915/307
• First Posted: Jun 12, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sweating, Gustatory; Zinc Oxide

Study Results

No Results Posted as of Jun 12, 2023