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
- Evaluations, Diagnostic Self
- Antimicrobial
- Orthodontic Appliance Complication
- Bacterial Overgrowth
- Dental White Spot
- Plaque Induced Gingivitis
- Plaque, Dental
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
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.