search
Back to results

ZnO Nanoparticles Coated Orthodontic Molar Tube (ZnONPs)

Primary Purpose

Evaluations, Diagnostic Self, Antimicrobial, Orthodontic Appliance Complication

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)
orthodontic molar tubes (control)
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Evaluations, Diagnostic Self focused on measuring Nanoparticles, zinc oxide nanoparticle, coating, orthodontic molar tube, electrophoretic deposition cell, EPD CELL, nanomaterials, antimicrobial effect, bacterial culture

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • University of Baghdad /college of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)

orthodontic molar tubes (control)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Evaluation of the antimicrobial Effect of ZnO Nanoparticles Coated orthodontic molar tube in relative to the uncoated orthodontic molar tube
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 Outcome Measures

Evaluate and compare the clinical bond failure rate between the coated orthodontic molar tube and the uncoated orthodontic molar tube
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.

Full Information

First Posted
October 4, 2023
Last Updated
October 11, 2023
Sponsor
University of Baghdad
search

1. Study Identification

Unique Protocol Identification Number
NCT06089720
Brief Title
ZnO Nanoparticles Coated Orthodontic Molar Tube
Acronym
ZnONPs
Official Title
An Antimicrobial Effect of ZnO Nanoparticles Coated Orthodontic Molar Tube (A Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
October 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluations, Diagnostic Self, Antimicrobial, Orthodontic Appliance Complication, Bacterial Overgrowth, Dental White Spot, Plaque Induced Gingivitis, Plaque, Dental
Keywords
Nanoparticles, zinc oxide nanoparticle, coating, orthodontic molar tube, electrophoretic deposition cell, EPD CELL, nanomaterials, antimicrobial effect, bacterial culture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
72 orthodontic molar tubes will be divided in two groups control 36 uncoated OMT, and 36 experimental groups that will receiving the zinc oxide nanoparticle coating.
Masking
ParticipantOutcomes Assessor
Masking Description
When applications of orthodontic molar tubes to patients mouth through routine orthodontic treatment, the clinicians will explain the procedure to patients without knowing the about which side coated or not .
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)
Arm Type
Experimental
Arm 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.
Arm Title
orthodontic molar tubes (control)
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
orthodontic molar tubes (control)
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of the antimicrobial Effect of ZnO Nanoparticles Coated orthodontic molar tube in relative to the uncoated orthodontic molar tube
Description
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.
Time Frame
After 2 weeks
Secondary Outcome Measure Information:
Title
Evaluate and compare the clinical bond failure rate between the coated orthodontic molar tube and the uncoated orthodontic molar tube
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhiaa Hu Al-Groosh, P.H.D
Organizational Affiliation
University of Baghdad
Official's Role
Study Director
Facility Information:
Facility Name
University of Baghdad /college of dentistry
City
Baghdad
State/Province
Bab Al Muadam
ZIP/Postal Code
51001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be mostly available on request.
Citations:
PubMed Identifier
30369970
Citation
Cerroni S, Pasquantonio G, Condo R, Cerroni L. Orthodontic Fixed Appliance and Periodontal Status: An Updated Systematic Review. Open Dent J. 2018 Sep 28;12:614-622. doi: 10.2174/1745017901814010614. eCollection 2018.
Results Reference
background
PubMed Identifier
32635196
Citation
Antonio-Zancajo L, Montero J, Albaladejo A, Oteo-Calatayud MD, Alvarado-Lorenzo A. Pain and Oral-Health-Related Quality of Life in Orthodontic Patients During Initial Therapy with Conventional, Low-Friction, and Lingual Brackets and Aligners (Invisalign): A Prospective Clinical Study. J Clin Med. 2020 Jul 3;9(7):2088. doi: 10.3390/jcm9072088.
Results Reference
background
PubMed Identifier
21484542
Citation
Erbe C, Hornikel S, Schmidtmann I, Wehrbein H. Quantity and distribution of plaque in orthodontic patients treated with molar bands. J Orofac Orthop. 2011 Mar;72(1):13-20. doi: 10.1007/s00056-010-0001-4. Epub 2011 Mar 11. English, German.
Results Reference
background
PubMed Identifier
24987641
Citation
Srivastava K, Tikku T, Khanna R, Sachan K. Risk factors and management of white spot lesions in orthodontics. J Orthod Sci. 2013 Apr;2(2):43-9. doi: 10.4103/2278-0203.115081.
Results Reference
background
PubMed Identifier
18678404
Citation
Beyth N, Houri-Haddad Y, Baraness-Hadar L, Yudovin-Farber I, Domb AJ, Weiss EI. Surface antimicrobial activity and biocompatibility of incorporated polyethylenimine nanoparticles. Biomaterials. 2008 Nov;29(31):4157-63. doi: 10.1016/j.biomaterials.2008.07.003. Epub 2008 Aug 3.
Results Reference
background
PubMed Identifier
18538253
Citation
Lim BS, Lee SJ, Lee JW, Ahn SJ. Quantitative analysis of adhesion of cariogenic streptococci to orthodontic raw materials. Am J Orthod Dentofacial Orthop. 2008 Jun;133(6):882-8. doi: 10.1016/j.ajodo.2006.07.027.
Results Reference
background
PubMed Identifier
22007663
Citation
Shah AG, Shetty PC, Ramachandra CS, Bhat NS, Laxmikanth SM. In vitro assessment of photocatalytic titanium oxide surface modified stainless steel orthodontic brackets for antiadherent and antibacterial properties against Lactobacillus acidophilus. Angle Orthod. 2011 Nov;81(6):1028-35. doi: 10.2319/021111-101.1.
Results Reference
background
Citation
Abdulhussein, D. A. (2022). AN ANTIMICROBIAL NANOPARTICLES COATED FIXED ORTHODONTIC RETAINER (AN IN VITRO STUDY). University of Baghdad.
Results Reference
background

Learn more about this trial

ZnO Nanoparticles Coated Orthodontic Molar Tube

We'll reach out to this number within 24 hrs