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Completed

NCT Number: NCT05898724

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

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.

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Key information

Conditions

Health Care Utilization Autonomic Nervous System Diseases Behavior Diet, Healthy Frey Syndrome Health Behavior Hyperhidrosis Nervous System Diseases Patient Acceptance of Health Care Skin Diseases Skin and Connective Tissue Diseases Sweat Gland Diseases Sweating, Gustatory Treatment Adherence and Compliance

Age range

16 year–20 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nasr city

Cairo, Cairo Governorate, 11311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Health Care Utilization.
  • Daily high calcium meals.
  • free from any systemic diseases.
  • Oral cavity is free from any injury or ulcers

Exclusion criteria

  • systemic diseases.
  • fracture of the jaw.
  • injuries or ulcers within the oral cavity

Treatment and study plan

Blank group

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. assessment of quality of oseointegration

    Time frame: 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 outcomes

  1. Microbial interaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2023
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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