| CTRI Number |
CTRI/2025/08/092493 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Surface properties and Antibacterial properties of Silver
Nanoparticle coated Stainless Steel Bands -“ A Randomized Controlled Trial |
|
Scientific Title of Study
|
Evaluation of Surface Characteristics and Antibacterial properties of Silver
Nanoparticle doped Stainless Steel Bands – A Randomized Controlled Trial |
| Trial Acronym |
none |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachamadugu Jahnavi |
| Designation |
post graduate student |
| Affiliation |
MAnipal College of Dental Sciences |
| Address |
Manipal college of dental sciences, Light House Hill road, Hampankatta, Manglore - 575001
Karnataka.
Manipal college of dental sciences, Light House Hill road, Hampankatta, Manglore - 575001
Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9441665650 |
| Fax |
|
| Email |
jahnavifeb18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asavari desai |
| Designation |
associate professor |
| Affiliation |
MAnipal College of Dental Sciences |
| Address |
Manipal college of dental sciences, Light House Hill road, Hampankatta, Manglore - 575001
Karnataka.
Manipal college of dental sciences, Light House Hill road, Hampankatta, Manglore - 575001
Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9483363045 |
| Fax |
|
| Email |
desaiasavari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachamadugu Jahnavi |
| Designation |
post graduate student |
| Affiliation |
MAnipal College of Dental Sciences |
| Address |
Manipal college of dental sciences, Light House Hill road, Hampankatta, Manglore - 575001
Karnataka.
Manipal college of dental sciences, Light House Hill road, Hampankatta, Manglore - 575001
Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9441665650 |
| Fax |
|
| Email |
jahnavifeb18@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rachamadugu Jahnavi |
| Address |
Manipal college of dental sciences, Light House Hill road, Hampankatta, Manglore - 575001
Karnataka. |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Jahnavi R |
manipal college of dental sciences |
KMC, Light house hill road
Flat no:7A,Brighton manor
Dakshina Kannada
KARNATAKA |
09441665650
jahnavifeb18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comitet, manipal college of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY VOLUNTEERS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
coated group |
group with silver nanoparticles coated bands 3months |
| Comparator Agent |
uncoated group |
group without any nanoparticle coating 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years
No antibiotic and antibacterial mouthwash
No history of smoking
No history of systemic diseases |
|
| ExclusionCriteria |
| Details |
Patients with compromised immune status
Pregnant women
Patients with syndromes and craniofacial anomalies
Patients with periodontal disease
Patients allergic to silver |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| antibacterial effect of silver nanoparticles |
after 1 and half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| surface smootehning after silver nanoparticle coating which will further decrease the antibacetrial adhesion |
after 1 and half year |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 randomized controlled trial evaluates the antibacterial efficacy and surface characteristics of silver nanoparticle coated orthodontic stainless steel bands
The study addresses plaque accumulation and white spot lesions common during fixed orthodontic treatment
Silver nanoparticles known for their antimicrobial properties are applied using physical vapor deposition
Surface roughness and bacterial adhesion will be analyzed using SEM EDX and ImageJ software
Eighteen participants are divided into coated and uncoated groups for comparison
The aim is to determine if AgNP coatings can reduce bacterial colonization and improve clinical outcomes |