| CTRI Number |
CTRI/2023/10/059148 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
14/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study evaluating the antimicrobial effect of silver nanoparticle coated orthodontic bands on streptococcus mutans |
|
Scientific Title of Study
|
Evaluation of Antimicrobial Effect of Silver Nanoparticle Coated Orthodontic Bands on Streptococcus mutans:
A Split Mouth Randomized Controlled Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragati Tule |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Dental College and Hospital, Navi Mumbai |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, MGM Dental College, Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9404740155 |
| Fax |
|
| Email |
tule.pragati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragati Tule |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Dental College and Hospital, Navi Mumbai |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, MGM Dental College, Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 410209
Department of Orthodontics & Dentofacial Orthopedics, MGM Dental College, Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9404740155 |
| Fax |
|
| Email |
tule.pragati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindranath VK |
| Designation |
Professor and Head of Department |
| Affiliation |
MGM Dental College and Hospital, Navi Mumbai |
| Address |
Department of Orthodontics & Dentofacial Orthopedics, MGM Dental College, Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 410209
Department of Orthodontics & Dentofacial Orthopedics, MGM Dental College, Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Phone |
08691809555 |
| Fax |
|
| Email |
raviymt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department no.10, Department of orthodontics and dentofacial orthopaedics, Room no 601,6th floor, MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of NH4 and Sion-Panvel express, Sector 18, Navi Mumbai, Maharashtra 410209 Raigarh MAHARASHTRA 410209 India |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital, Navi Mumbai |
| Address |
MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE Junction of
NH4 and Sion-Panvel express, Sector 18, Navi Mumbai,
Maharashtra 410209
Raigarh
MAHARASHTRA
410209
India |
| Type of Sponsor |
Private hospital/clinic |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pragati Tule |
MGM DENTAL COLLEGE AND HOSPITAL |
Department no. 10, Department of orthodontics and dentofacial orthopaedics, Room no. 601, 6th floor, Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA |
9404740155
tule.pragati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, MGM Dental College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malocclusion requiring orthodontic treatment and placement of orthodontic bands |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Silver nanoparticle coated orthodontic bands |
Silver nanoparticle coating will be done on orthodontic bands and they will be evaluated for their antimicrobial activity against streptococcus mutans.
Duration for intervention: 1 month |
| Comparator Agent |
uncoated orthodontic bands |
uncoated orthodontic bands will be simultaneously placed on other side of mouth and they will be compared against silver nanoparticle coated bands for activity against streptococcus mutans |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients coming to the department of orthodontics, undertaking orthodontic treatment
2)Patient giving consent for the study
3)Medical coating of silver nanoparticles on bands (carried out by PVD technique)
|
|
| ExclusionCriteria |
| Details |
1)Any other medical coating than silver nanoparticles
2)Patients with systemic disease
3)Patient taking any antibiotic medications
4)Patients with periodontal disease
5)Patients with active caries on the site of placement of band
• Patients with age below 18 and above 35 years
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to evaluate the antimicrobial effectiveness of silver nanoparticle coated orthodontic bands on streptococcus mutans.The count of streptococcus mutans around the bands coated with silver nanoparticle after removing them a month after the placement will be recorded and will be compared to the count of streptococcus mutans around the uncoated bands. |
After the bands are placed in the mouth, 1 month after the placement, the bands both coated and uncoated will be removed and they will be assesed for antimicrobial activity against streptococcus mutans |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome is to check the retention of silver nanoparticles on bands |
it will be checked after 1 month of band placement |
|
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Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| 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="0"
Months="6"
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
|
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Brief Summary
|
The study is A Split Mouth Randomized Controlled Study. Silver nanoparticles have been used in dentistry in various fields such as endodontics, periodontics because of its antimicrobial activity. Recently silver nanoparticles have been introduced in orthodontics for coating of bands. In vitro studies have shown the antimicrobial activity of silver nanoparticles. This study intends to evaluate the clinical efficiency of silver nanoparticle coated orthodontic bands on commonly found oral pathogen streptococcus mutans. For this study, patients coming to the department of orthodontics will be selected as per Convenient, Consecutive, Consenting sampling for their participation in the study. A sample size of 14 patients will be taken (n=14). Two groups will be taken in each patient: Group A (Uncoated Bands) and Group B (AgNP Coated Bands). FESEM and EDS tests will be done prior to placing the bands in patients to check the surface characteristics of bands. Allocation of bands in patient’s mouth either on left or right side will be based on block randomization technique. Bands will be removed from patient’s mouth after 1 month of placement. Bands will be checked for streptococcus mutans count by counting CFU/ml and FESEM and EDS tests to check retention of nanoparticles. Results will be obtained in the form of images and graphs for FESEM and EDS test and in the form of CFU/ml for bacterial count test.
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