ZnO Nanoparticles Coated Orthodontic Molar Tube (ZnONPs)

University of Baghdad

Status: Completed

Conditions: Plaque Induced Gingivitis; Antimicrobial; Orthodontic Appliance Complication; Bacterial Overgrowth; Dental White Spot; Plaque, Dental; Evaluations, Diagnostic Self

Treatments: Device: orthodontic molar tubes (control); Device: Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)

Study type: Interventional

Funder types: Other

Identifiers

NCT06089720

782423

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 14 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)

Experimental group

Description:

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.

Treatment:

Device: Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)

orthodontic molar tubes (control)

Placebo Comparator group

Description:

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.

Treatment:

Device: orthodontic molar tubes (control)