ZnO Nanoparticles Coated Orthodontic Molar Tube

NCT06089720 | Completed

• 1 other identifier: 782423
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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. .

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  After 2 weeks

Secondary Outcomes (1)

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

  3 months

Study Arms (2)

Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)

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)

orthodontic molar tubes (control)

PLACEBO COMPARATOR

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)

Interventions

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.

Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)

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.

orthodontic molar tubes (control)

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad /college of dentistry

Baghdad, Bab Al Muadam, 51001, Iraq

Location

Related Publications (8)

• 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.

  PMID: 30369970 BACKGROUND

• 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.

  PMID: 32635196 BACKGROUND

• 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.

  PMID: 21484542 BACKGROUND

• 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.

  PMID: 24987641 BACKGROUND

• 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.

  PMID: 18678404 BACKGROUND

• 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.

  PMID: 18538253 BACKGROUND

• 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.

  PMID: 22007663 BACKGROUND

• Abdulhussein, D. A. (2022). AN ANTIMICROBIAL NANOPARTICLES COATED FIXED ORTHODONTIC RETAINER (AN IN VITRO STUDY). University of Baghdad.

  BACKGROUND

MeSH Terms

Conditions

Dental Caries; Dental Plaque

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits

Study Officials

• Dhiaa Hu Al-Groosh, P.H.D

  University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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 .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 18, 2023
• Study Start: February 15, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 4, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)