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

NCT05898724 | Completed DMC

• 1 other identifier: 915/307
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Utilization; Diet, Healthy; Frey Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbial interaction

  three months

Study Arms (3)

Blank group

EXPERIMENTAL

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

Silver hydroxyapatite group:

EXPERIMENTAL

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

Zinc oxide group

EXPERIMENTAL

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

Interventions

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.

Blank group

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.

Silver hydroxyapatite group:

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.

Zinc oxide group

Eligibility Criteria

• Age: 16 Years - 20 Years
• Gender Eligibility Details: The current study will conduct on eighteen Egyptian males.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Nasr city

Cairo, Cairo Governorate, 11311, Egypt

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care; Sweating, Gustatory

Interventions

Zinc Oxide

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Autonomic Nervous System Diseases; Nervous System Diseases; Hyperhidrosis; Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oxides; Oxygen Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Mahmoud MF Abo - Elmahasen, PHD

  Lecturer of orthodontics - Faculty of dental medicine - Al-Azhar university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecture of orthodontics - Faculty of dental medicine

Model Details: 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).

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 12, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)