ZnO Nanoparticles Coated Orthodontic Molar Tube (ZnONPs)

October 11, 2023 updated by: Ahmed Kamil Jawad, University of Baghdad

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

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. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Bab Al Muadam
      • Baghdad, Bab Al Muadam, Iraq, 51001
        • University of Baghdad /college of dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who are seeking or under orthodontic treatment with fixed appliances Subjects must be healthy &well fit medically.

    • Subjects with no signs or symptoms of oral mucosal disease.
    • Subjects should not receive oral antimicrobials or antibiotic therapy for more than 3 months prior to sample enrolling.
    • non-pregnant or lactating Female patient.
    • Subjects is not smokers

Exclusion Criteria:

  • Patients with a greater tendency to accumulate plaque (e.g., having congenital anomalies such as cleft lip and palate) or undergo orthognathic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)
The nine orthodontic patients will receive 36 orthodontic molar tubes coated with ZnO nanoparticle in split-mouth cross quadrant manner, In each patient, two diagonal quadrants (i.e., upper right and lower left, or vice versa) will randomly assigned to each coated OMT and UOMT groups. evaluation will be after 2 weeks for microbial assessment biofilm in addition to plaque & gingival index. patients will be follow up for 3 month to evaluation bond failure rate.
Device: Zinc 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.
Placebo Comparator: orthodontic molar tubes (control)
The nine orthodontic patients will receive 36 the non-coated orthodontic molar tube in split-mouth cross quadrant manner, In each patient, two diagonal quadrants (i.e., upper right and lower left, or vice versa) will randomly assigned to each coated OMT and UOMT groups. evaluation will be after 2 weeks for microbial assessment biofilm in addition to plaque & gingival index. patients will be follow up for 3 month to evaluation bond failure rate.
Device: orthodontic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the antimicrobial Effect of ZnO Nanoparticles Coated orthodontic molar tube in relative to the uncoated orthodontic molar tube
Time Frame: After 2 weeks
Compare the antimicrobial properties of the zno nanoparticle coated OMT in relative to uncoated orthodontic molar tube (UOMT), through taking swaps from patient and sent to laboratory to culturing swaps samples to evaluating the colony forming unit number of S. mutans&lactobacillus bacteria which consider mean cause of white spot lesion and compare with the uncoated orthodontic molar tube swaps cultures.
After 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate and compare the clinical bond failure rate between the coated orthodontic molar tube and the uncoated orthodontic molar tube
Time Frame: 3 months
By following up patients for 3 months recording the bond failure occurs through out the this period with date and location of debond tubes for coated and uncoated orthodontic molar tubes.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Study Director: Dhiaa Hu Al-Groosh, P.H.D, University of Baghdad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 4, 2023

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 782423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be mostly available on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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