Clinical Trials Directory

Trials / Completed

CompletedNCT06089720

ZnO Nanoparticles Coated Orthodontic Molar Tube

An Antimicrobial Effect of ZnO Nanoparticles Coated Orthodontic Molar Tube (A Randomized Clinical Trial)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
University of Baghdad · Academic / Other
Sex
All
Age
14 Years – 30 Years
Healthy volunteers
Accepted

Summary

Orthodontic treatment is an elective procedure to improve the patient's dentofacial appearance. The complex design of fixed appliances provides a platform that leads to increased plaque accumulation around orthodontic brackets. So, the risk to develop demineralization area adjacent to orthodontic brackets is a major barrier in achieving this goal. Oral hygiene is greatly complicated following the placement of fixed orthodontic Appliances. Molar tube in place are considered for nearly all patients experiencing fixed orthodontic therapy over the whole treatment period, which normally lasts 1.5 to 2 years. To the best of the authors' knowledge, the application and antimicrobial efficacy of zinc oxide (ZnO) nanoparticles coating on orthodontic molar tube material has not been integrated clinically. White spot lesions during orthodontic treatment have a documented etiology. Briefly, the accumulation of plaque and food around brackets, bands, wires, and other attachments caused decreased pH and increased S. mutans colonization, which led to the possibility of clinical demineralization. The aims of study are to assess the antimicrobial effect of nanoparticle coated stainless steel orthodontic molar tube material (OMT) with zinc oxide (ZnO) nanoparticles in relative to uncoated orthodontic molar tube (UOMT) against the streptococcus. mutans\& lactobacllius bacteria that cause white spot lesion around the fixed orthodontic appliance. .

Detailed description

Aim: The aim of this prospective randomized clinical trial is to assess the antimicrobial efficacy of nanoparticle coating stainless steel orthodontic molar tube (OMT) with zinc oxide (ZnO) nanoparticles in relative to uncoated orthodontic molar tube (UOMT). Objectives: 1. Compare the antimicrobial properties of the zno nanoparticle coated OMT in relative to uncoated orthodontic molar tube (UOMT). 2. Evaluate and compare the clinical bond failure rate between the coated OMT and the UOMT. The null hypothesis is that there is no significant difference in the antimicrobial effects and the rate of bond failure between the non-coated and coated stainless steel orthodontic molar tube using ZnO NPs.

Conditions

Interventions

TypeNameDescription
DEVICEZinc oxide nanoparticle coated orthodontic molar tubes (experimental)nine orthodontic patients each one will receive 2 coated zinc oxide nanoparticle molar tubes in split-mouth manner and will assess for antimicrobial effect on s. mutans \& lactobacillus after two weeks, in addition to evaluation of bond failure rate after three months.
DEVICEorthodontic molar tubes (control)nine orthodontic patients each one will receive two uncoated molar tubes in split-mouth manner and will assess for antimicrobial effect on S. mutans \& lactobacillus after two weeks, also, evaluation of the bond failure rate after three months period.

Timeline

Start date
2023-02-15
Primary completion
2023-09-30
Completion
2023-10-04
First posted
2023-10-18
Last updated
2023-10-18

Locations

1 site across 1 country: Iraq

Source: ClinicalTrials.gov record NCT06089720. Inclusion in this directory is not an endorsement.