| CTRI Number |
CTRI/2025/10/096600 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to Compare Bacterial Adhesion and Surface Changes on Zinc Oxide Nanocoated and Uncoated Orthodontic Wires in Patients |
|
Scientific Title of Study
|
Comparative evaluation of surface morphology and Streptococcus mutans adhesion on retrieved Zinc Oxide nanoparticle coated stainless steel archwire vs uncoated wires- A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gunika Tayal |
| Designation |
MDS resident |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital Pune |
| Address |
Room no.314, Department of Orthodontics and Dentofacial Orthopedics, Bharati Vidyapeeth (Deemed to be University)Dental College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
09896269556 |
| Fax |
|
| Email |
gunikatayal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veera Bhosale |
| Designation |
Head of Department, Professor |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) Dental College and Hospital Pune |
| Address |
Room no. 314, Department of Orthodontics and Dentofacial Orthopedics, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7875571938 |
| Fax |
|
| Email |
veera.bhosale@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunika Tayal |
| Designation |
MDS resident |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University)Dental College and Hospital Pune |
| Address |
Room no. 314, Department of Orthodontics and Dentofacial Orthopedics, Bharati Vidyapeeth (Deemed to be University)Dental College and Hospital, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
09896269556 |
| Fax |
|
| Email |
gunikatayal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Gunika Tayal |
| Address |
Room no. 314, Department of Orthodontics and Dentofacial Orthopedics, Bharati Vidyapeeth(Deemed to be University) Dental College and Hospital, Pune 411043, India |
| Type of Sponsor |
Other [(self)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gunika Tayal |
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune |
Room no. 314, Department of Orthodontics and Dentofacial Orthopedics, Bharati Vidyapeeth (Deemed to be University)Dental College and Hospital, Pune
Pune
MAHARASHTRA |
09896269556
gunikatayal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients Requiring fixed Orthodontic Treatment |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nanoparticle coated stainless steel wires |
Zinc Oxide coating on 16x22 inch stainless steel wires used for orthodontic treatment |
| Comparator Agent |
Uncoated stainless steel wire |
Stainless Steel 16x22 inch rectangular wire used for orthodontic treatment |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age 12 to 30 years
Patients requiring fixed orthodontic treatment with 0.022 MBT prescription
Good general, gingival, and periodontal health |
|
| ExclusionCriteria |
| Details |
Systemic disorders
Use of antibiotics or anti-inflammatory drugs in last 3 months
Poor oral hygiene
Known metal allergy
Habit of pan masala or tobacco chewing, alcohol or aerated drink consumption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate streptococcus mutans adhesion |
after 4-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| surface morphology (AFM analysis) |
after 4-6 weeks |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
02/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - after due publication with an indexed journal
- For how long will this data be available start date provided 14-07-2026 and end date provided 08-07-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present study is a randomized split mouth clinical trial conducted on patients undergoing fixed orthodontic treatment. The purpose of the study is to compare the surface morphology and Streptococcus mutans adhesion on zinc oxide nanoparticle coated stainless steel archwires with uncoated stainless steel archwires after 4 to 6 weeks of intraoral use. The intervention group will receive 0.016 x 0.022 inch stainless steel archwires coated with zinc oxide nanoparticles while the control group will receive uncoated 0.016 x 0.022 inch stainless steel archwires. A total of 18 patients aged 12 to 30 years requiring orthodontic treatment with 0.022 MBT prescription brackets and with good oral and periodontal health will be included in the study. Patients with systemic disorders, poor oral hygiene, known metal allergies, history of antibiotic or anti inflammatory drug use in the past three months, or habits such as tobacco chewing, alcohol consumption will be excluded. The primary outcome of the study is the evaluation of Streptococcus mutans adhesion by colony count method. The secondary outcome is the assessment of surface morphology of retrieved wires using atomic force microscopy. Statistical analysis will be performed using SPSS version 21 with appropriate parametric or non parametric tests. A confidence interval of 95 percent, a significance level of 5 percent and a study power of 90 percent will be applied. |