ZnO Nanoparticles Coated Orthodontic Molar Tube

Orthodontic Appliance Complication Clinical Trial

— ZnONPs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06089720
• Other study ID #: 782423
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: October 4, 2023

Study information

• Verified date: October 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 4, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Antimicrobial
• Bacterial Overgrowth
• Dental Caries
• Dental Plaque
• Dental White Spot
• Evaluations, Diagnostic Self
• Gingivitis
• Orthodontic Appliance Complication
• Plaque Induced Gingivitis
• Plaque, Dental

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iraq	University of Baghdad /college of dentistry	Baghdad	Bab Al Muadam

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

References & Publications (8)

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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months