| CTRI Number |
CTRI/2025/11/097853 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing if Zinc Oxide and Sodium Hyaluronate coated Wire when used during orthodontic treatment will provide better treatment outcomes compared to those with uncoated wires. |
|
Scientific Title of Study
|
Development and Evaluation of Clinical efficacy of Novel Zinc oxide and Sodium Hyaluronate coated Stainless steel orthodontic archwire -Randomised control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Najiya VP |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha Dental College, Chennai |
| Address |
Department of orthodontics(Clinic 27), Saveetha Dental College, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8943185066 |
| Fax |
|
| Email |
152308005.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shantha Sundari |
| Designation |
Professor,Dept of Orthodontics,Saveetha Dental College |
| Affiliation |
Saveetha Dental College, Chennai |
| Address |
162, Poonamallee High Road, Chennai 600077 India.
162, Poonamallee High Road, Chennai 600077 India.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9444443640 |
| Fax |
|
| Email |
shanthakkss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Najiya VP |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha Dental College, C hennai |
| Address |
B 909, 72/1, Poonamallee High Rd, opp. Saveetha Dental College, Senneer Kuppam, Chennai, Tamil Nadu
TAMIL NADU
600077
India |
| Phone |
8943185066 |
| Fax |
|
| Email |
152308005.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College,162, Poonamallee High Road, Chennai 600077 |
|
|
Primary Sponsor
|
| Name |
Najiya VP |
| Address |
postgraduate student, dept of orthodontics, Saveetha dental college, No.162,Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, 600077, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Saveetha Dental College |
Saveetha Dental College and Hospitals. 162, Poonamallee High Road, Chennai 600077 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Najiya VP |
Saveetha Dental College and Hospitals. |
Clinic 27, Department of Orthodontics, 5th floor.
Thiruvallur
TAMIL NADU |
8943185066
152308005.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
| Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Uncoated 0.019 x 0.025 orthodontic arch wire |
The uncoated half of the same 0.019×0.025-inch stainless steel orthodontic archwire will serve as the comparator (control). It will undergo no surface modification or coating. Comparative evaluation between the coated and uncoated halves will assess frictional resistance, microbial adhesion, cytotoxicity, coating stability, and clinical tooth movement rate over a 3-month period. |
| Intervention |
ZnO-SH coated 0.019 x 0.025 orthodontic arch wire |
Split-mouth study using 0.019×0.025-inch stainless steel orthodontic archwires where one half of each wire is coated with zinc oxide and sodium hyaluronate by Physical Vapor Deposition (E-beam). The other half remains uncoated, serving as control. The coated side is expected to show reduced friction, better biocompatibility, and antimicrobial activity during fixed orthodontic treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
All 4 or upper 4 extraction cases ( upper 1 st premolar extraction cases)after end of levelling and aligning.
|
|
| ExclusionCriteria |
| Details |
Patient with systemic illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Rate of tooth movement
2. Bacterial adhesion
|
1. Rate of tooth movement- 3 months
2. Bacterial adhesion-1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. coating wear and surface roughness of archwire
2.Notching of the archwire after retraction. |
1. coating wear and surface roughness of the archwire - 1month
2.Notching of the archwire after retraction-3-6months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study investigates the clinical efficacy of stainless steel orthodontic archwires coated with zinc oxide and sodium hyaluronate using physical vapor deposition. The research evaluates cytotoxicity, antimicrobial activity, surface properties, and frictional behavior of the coated wires. In vivo, the trial assesses rate of tooth movement, bacterial adhesion, periodontal health, and coating durability in patients undergoing fixed appliance therapy. Findings are expected to demonstrate reduced friction, improved antimicrobial resistance, and enhanced orthodontic outcomes compared to uncoated wires. |