| CTRI Number |
CTRI/2023/11/060313 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the bacterial efficacy of zinc oxide nanoparticle coated vs uncoated modules |
|
Scientific Title of Study
|
Antibacterial efficacy of zinc oxide nanoparticle coated elastomeric modules- 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 |
DrHemashree J |
| Designation |
Postgraduate Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Orthodontics And Dentofacial Orthopedics,
Room no. 9, 1st floor, Sri Ramachandra Dental College and Hospitals,
Sri Ramachandra Institute of Higher Education and Research (DU),
No.1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9941965274 |
| Fax |
|
| Email |
d0421003@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sridevi Padmanabhan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Orthodontics And Dentofacial Orthopedics,
Room no. 9, 1st floor, Sri Ramachandra Faculty of Dental Sciences,
Sri Ramachandra Institute of Higher Education and Research (DU),
No.1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9600077428 |
| Fax |
|
| Email |
sridevipadu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sridevi Padmanabhan |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Orthodontics And Dentofacial Orthopedics,
Room no. 9, 1st floor, Sri Ramachandra Faculty of Dental Sciences,
Sri Ramachandra Institute of Higher Education and Research (DU),
No.1, Ramachandra Nagar, Porur
TAMIL NADU
600116
India |
| Phone |
9600077428 |
| Fax |
|
| Email |
sridevipadu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Resident Stipend Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
Dr. Hemashree J |
| Address |
C3 F4 VGN Imperia phase - III VGN Mahalakshmi Nagar Thiruverkadu Chennai - 600077 |
| 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 Hemashree J |
Sri Ramachandra Dental College and Hospital |
Room No.9,Department of Orthodontics and Dentofacial Orthopedics,Sri Ramachandra
Institute of Higher
Education and
Research, No.1,
Ramachandra Nagar,
Porur
Chennai
TAMIL NADU |
9941965274
d0421003@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Orthodontic need patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nanoparticle
coated elastomeric modules |
Orthodontic modules will be coated with zinc oxide nanoparticle through Radio Frequency magnetron sputtering method which will be evaluated end of one month and end of one year |
| Comparator Agent |
Uncoated elastomeric modules |
This will be compared to the coated modules which will be evaluated end of one month and end of one year |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing orthodontic treatment
Non- extraction fixed appliance cases
Patients with good OHI.
Patients not taking medication
Patients with no relevant medical history.
Patients with permanent dentition with full complement of teeth
Patients with good gingival and periodontal
health |
|
| ExclusionCriteria |
| Details |
Patients with poor oral hygiene
Patients with extensive dental caries
Patients with no history of illness or allergies.
Patients with periodontitis and bone loss.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate
streptococcus mutans concentration in plaque
using real-time
polymerase chain reaction (PCR) and white spot lesion formation |
End of 3 months and end of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
11/12/2023 |
| 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="1"
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
|
Certain studies have evaluated the antibacterial efficacy of nanoparticle coated brackets and nanoparticle incorporated composite separately and studies have only evaluated the short term efficacy of nanoparticles on the cariogenic bacterial in the plaque. No studies have compared the efficacy of nanoparticle coated elastomeric modules over the uncoated modules. Long term studies are required to evaluate whether the efficacy of nanoparticles extends to reduced incidence of white spot lesions. Therefore, this study was designed to compare the efficacy of noanoparticles coated on elastomeric modules on long term against streptococcus mutans concentration in plaque and on the incidence of white spot lesions. |