| CTRI Number |
CTRI/2024/12/078661 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of biosynthetically developed nanosilver coated elastomeric
orthodontic modules |
|
Scientific Title of Study
|
Green synthesised silver nanoparticle coated elastomeric ligatures on patients undergoing orthodontic treatment |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjusha Divakar |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic no 27
Dept of Orthodontics
169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur TAMIL NADU 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9790440604 |
| Fax |
|
| Email |
anjusharao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Mathew George |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 27
Department of Orthodontics
169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur TAMIL NADU 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9840032771 |
| Fax |
|
| Email |
ashwin.george10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin Mathew George |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 27
Department of Orthodontics
169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur TAMIL NADU 600077 India
Chennai
TAMIL NADU
600077
India |
| Phone |
9840032771 |
| Fax |
|
| Email |
ashwin.george10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dental matrix,Authorised distributor of Ormco,No 601,HMT Layout ,RT Nagar,Bengaluru 560032 |
|
|
Primary Sponsor
|
| Name |
D.Divakar |
| Address |
Kalladi Assainar road,Perimbadari,Mannarkkad,Palakkad,Kerala
678582 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Saveetha Dental college and Hospital |
No 162, Poonamallee High Road Velappanchavadi 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 |
| DrAnjusha Divakar |
Saveetha Dental college and hospital |
Clinic 27
Department of Orthodontics
No 162, Poonamallee High Road Velappanchavadi Chennai 600077
Chennai
TAMIL NADU |
9790440604
anjusharao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College-Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Elastomeric ligatures |
Patients undergoing fixed orthodontic treatment,orthodontic wires are secured within the brackets with elastomeric ligatures for 4 weeks and it will be replaced by next set of ligatures in the following visit. |
| Intervention |
Elastomeric ligatures coated with green synthesised silver nanoparticles |
On patients undergoing orthodontic treatment, green synthesised silver nanoparticle coated elastomeric ligatures to be used for holding the arch wire in place within the brackets for 4 weeks and it will be replaced by next set of ligatures in the following visit. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Orthodontic treatment with fixed appliance.
MBT brackets
|
|
| ExclusionCriteria |
| Details |
Self lighting brackets
Clear aligner technique
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Enamel demineralisation
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anti microbial property
Physical properties-Tensile strength,modulus of elasticity ,Colour stability |
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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)
|
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 - 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 - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anjusharao@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - No
|
|
Brief Summary
|
Green synthesised silver nanoparticle coated elastomeric ligatures on patients undergoing orthodontic treatment-A split mouth study
Aim-The aim of the study is to prepare, develop and test green synthesised nano silver coated elastomeric ligatures
Objective and rationale-Commercially available elastomeric ligature have disadvantages with regards to excessive plaque accumulation resulting in demineralisation of enamel manifesting as white spot lesions. Also,there is a constant degradation of its elasticity with time, exposure to oral fluids.Therefore the incorporation of silver nano coating in elastomeric modules to study the antibacterial effect, extent of demineralisation and other physical properties.
Sample size-20 patients
A split mouth study
Methodology-
The methodology involves synthesizing and characterizing silver nanoparticles using plant extracts from clove and cardamom. These nanoparticles will then be coated to elastomeric ligatures through an electron beam sputtering process. The sample size, determined using G*Power version 3.0.1 with a power of 0.8, consists of 20 patients undergoing fixed orthodontic treatment with the MBT system. The study adopts a split-mouth design in patients undergoing fixed orthodontic treatment with the MBT system, focusing on cases requiring the extraction of all premolars or upper premolars. On one side, commercially available elastomeric ligatures will be used, while on the contralateral side, elastomeric ligatures coated with green synthesis silver nanoparticles (synthesized using clove and cardamom extracts via electron beam sputtering) will be applied. After 3 months, the designated premolars from both sides will be extracted and analyzed using scanning electron microscopy (SEM) to evaluate enamel demineralization. Additional assessments will include the antibacterial properties, tensile strength, modulus of elasticity, and color stability of the elastomeric ligatures. Informed consent will be obtained from all participants for the use of their case records and extracted teeth in research and publication.These patients will have their ligatures coated with silver nanoparticles. Informed consent will be obtained from all participants for the use of their case records in scientific research and publication. |