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NCT Number: NCT06089720

ZnO Nanoparticles Coated Orthodontic Molar Tube

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. .

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Key information

Conditions

Evaluations, Diagnostic Self Antimicrobial Bacterial Overgrowth Dental Caries Dental Deposits Dental Plaque Dental White Spot Orthodontic Appliance Complication Plaque Induced Gingivitis Plaque, Dental Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Baghdad /college of dentistry

Baghdad, Bab Al Muadam, 51001, Iraq

About this study

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:

  • Compare the antimicrobial properties of the zno nanoparticle coated OMT in relative to uncoated orthodontic molar tube (UOMT).
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)

Device

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.

orthodontic molar tubes (control)

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Acronym: ZnONPs

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2023
Registry last updated
Oct 18, 2023

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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