Evaluations, Diagnostic SelfZnONPsNCT06089720
ZnO Nanoparticles Coated Orthodontic Molar Tube
A study testing Zinc oxide nanoparticle coated orthodontic molar tubes (experimental) in people with Evaluations, Diagnostic Self and Antimicrobial, run by University of Baghdad at 1 site in Iraq.
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. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluations, Diagnostic Self, Antimicrobial, Orthodontic Appliance Complication
- What is being tested?
- Zinc oxide nanoparticle coated orthodontic molar tubes (experimental)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteIraq
- Study dates
- 15 Feb 2023to 4 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with a greater tendency to accumulate plaque (e.g., having congenital anomalies such as cleft lip and palate) or undergo orthognathic surgery
Trial locations and contacts
1 site in 1 country.
Iraq1 site
University of Baghdad /college of dentistry
Baghdad, Bab Al Muadam, 51001
About this study
Official title: An Antimicrobial Effect of ZnO Nanoparticles Coated Orthodontic Molar Tube (A Randomized Clinical Trial)
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. .
Read the 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.
- Conditions
- Evaluations, Diagnostic Self, Antimicrobial, Orthodontic Appliance Complication, Bacterial Overgrowth, Dental White Spot, Plaque Induced Gingivitis
- Being tested
- Zinc oxide nanoparticle coated orthodontic molar tubes (experimental), orthodontic molar tubes (control)
- Keywords
- Nanoparticles, zinc oxide nanoparticle, coating, orthodontic molar tube, electrophoretic deposition cell, EPD CELL, nanomaterials, antimicrobial effect, bacterial culture
- Medical subject headings
- Dental Caries, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: orthodontic molar tubes (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Feb 2023
- Primary completion30 Sep 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Evaluations, Diagnostic SelfStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kamil Jawad, University of Baghdad
- Investigators
- Dhiaa Hu Al-Groosh, P.H.D, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089720
- Sponsor's protocol ID
- 782423
- Acronym
- ZnONPs
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be mostly available on request.
Publications
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.
PubMed 30369970Antonio-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.
PubMed 32635196Erbe 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.
PubMed 21484542Srivastava 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.
PubMed 24987641Beyth 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.
PubMed 18678404Lim 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.
PubMed 18538253Shah 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.
PubMed 22007663Abdulhussein, D. A. (2022). AN ANTIMICROBIAL NANOPARTICLES COATED FIXED ORTHODONTIC RETAINER (AN IN VITRO STUDY). University of Baghdad.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Antimicrobial Effect of ZnO Nanoparticles Coated Orthodontic Molar Tube (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06089720
- Acronym / sponsor ID
- ZnONPs / 782423
- Conditions
- Evaluations, Diagnostic Self, Antimicrobial, Orthodontic Appliance Complication, Bacterial Overgrowth, Dental White Spot, Plaque Induced Gingivitis
- Keywords
- Nanoparticles, zinc oxide nanoparticle, coating, orthodontic molar tube, electrophoretic deposition cell, EPD CELL, nanomaterials, antimicrobial effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Zinc oxide nanoparticle coated orthodontic molar tubes (experimental) | Experimental | Device: Zinc oxide nanoparticle coated orthodontic molar tubes (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. |
| orthodontic molar tubes (control) | Placebo comparator | Device: orthodontic molar tubes (control)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. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients who are seeking or under orthodontic treatment with fixed appliances Subjects must be healthy \&well fit medically.
Key exclusion criteria (1 listed)
- Patients with a greater tendency to accumulate plaque (e.g., having congenital anomalies such as cleft lip and palate) or undergo orthognathic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Zinc oxide nanoparticle coated orthodontic molar tubes (experimental) |
| 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. | Device | orthodontic molar tubes (control) |
Primary outcome
Evaluation of the antimicrobial Effect of ZnO Nanoparticles Coated orthodontic molar tube in relative to the uncoated orthodontic molar tube
Time frame: After 2 weeks
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.
1 secondary outcome
Evaluate and compare the clinical bond failure rate between the coated orthodontic molar tube and the uncoated orthodontic molar tube
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Background: PubMed 30369970Cerroni 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.
- Background: PubMed 32635196Antonio-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.
- Background: PubMed 21484542Erbe 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.
- Background: PubMed 24987641Srivastava 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.
- Background: PubMed 18678404Beyth 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.
- Background: PubMed 18538253Lim 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.
- Background: PubMed 22007663Shah 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.
- BackgroundAbdulhussein, D. A. (2022). AN ANTIMICROBIAL NANOPARTICLES COATED FIXED ORTHODONTIC RETAINER (AN IN VITRO STUDY). University of Baghdad.
- Individual participant dataSharing planned: No. It will be mostly available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhiaa Hu Al-Groosh, P.H.D study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc oxide nanoparticle coated orthodontic molar tubes (experimental) in people with Evaluations, Diagnostic Self and Antimicrobial, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the antimicrobial Effect of ZnO Nanoparticles Coated orthodontic molar tube in relative to the uncoated orthodontic molar tube (time frame: After 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06089720, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.