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CTRI Number  CTRI/2024/04/064981 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Assessment of the antimicrobial efficacy of orthodontic adhesive enhanced with silver nanoparticles: An In Vivo Study 
Scientific Title of Study   An Evaluation of antimicrobial property of orthodontic adhesive modified with silver nanoparticles : An In Vivo Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Urja Modi 
Designation  MDS student 
Affiliation  Manubhai Patel Dental college, Vadodara 
Address  Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near Vidyakunj School , Mujmahuda, Vadodara, Gujarat ,390011

Vadodara
GUJARAT
390011
India 
Phone  09909269289  
Fax    
Email  urja.modii@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikunj Patel 
Designation  Professor 
Affiliation  Manubhai Patel Dental college and Hospital 
Address  Department of orthodontics and dentofacial orthopedics, Manubhai Patel Dental college and hospital, Vishwajyoti Ashram Near Vidyakunj School , Mujmahuda, Vadodara, Gujarat ,390011

Vadodara
GUJARAT
390011
India 
Phone  8128460652  
Fax    
Email  nikunj_84@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Urja Modi 
Designation  MDS Student 
Affiliation  Manubhai Patel Dental College 
Address  1,Ajit society, baghikhana road,navapura Opposite polo ground
Department of Orthodontics and Detofacial Orthopaedics , Manubhai Patel Dental Hospital , Vishwajyoti Ashram,near Vidyakunj school, Muj mahuda, vadodara, gujarat , 390011
Vadodara
GUJARAT
390001
India 
Phone  09909269289  
Fax    
Email  urja.modii@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthodontics and Dentofacial Orthopedics, Manubhai Patel Dental college and Hospital, Vadodara, Gujarat  
 
Primary Sponsor  
Name  Dr Urja Modi 
Address  1 Ajit society, opp polo ground, baghikhana road, Vadodara, 390001 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Urja Modi  Manubhai Patel Dental College and Hospital  Department of Orthodontics and Dentofacial Orthopaedics , Manubhai Patel Dental Hospital, Vishwajyoti Ashram , Near Vidyakunj School, Muj mahuda , vadodara , 390011
Vadodara
GUJARAT 		 9909269289

urja.modii@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (IEC) FOR RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Malaligned teeth  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Orthodontic adhesive without silver nanoparticles added  Conventional Orthodontic adhesive without silver nanoparticles. 
Intervention  Silver nanoparticles  Mixing silver nanoparticles in orthodontic adhesive and bonding brackets with it. Total duration - 1.5 months 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with mild to no crowding requiring fixed orthodontic treatment, Good oral hygiene and healthy periodontium
 
 
ExclusionCriteria 
Details  Patients who do not give consent for the study

Patients with asymmetric crowding

Patients with compromised periodontium 

Systemic illnesses like Diabetes mellites, AIDS, patients on medication like phenytoin, or immunosuppressants.

Missing teeth in anterior region

Patients with localized gum disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Check antimicrobial property of the adhesive   Plaque sample collected after 21 days from experimental site and control site 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the antimicrobial property of new adhesive with the conventional adhesive  after 21 days of bonding 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   09/04/2024 
Date of Study Completion (India) 12/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 will be a split mouth in-vivo study. 25 patients undergoing orthodontic treatment will be selected for the study. Each participant will be treated with  0.022 x 0.028” slot metal MBT bracket system.

•Participants will be allocated into 2 sides using lottery method ; so the brackets on one side of the patient will be bonded with orthodontic adhesive with silver nanoparticles and the other side brackets will be bonded with orthodontic adhesive without silver NP. Control side will be the adhesive without silver NP. Experimental side will be the silver

 containing adhesive side.

 

•The experiment will be a  single blinded study  conducted by keeping the technician blinded about the groups to prevent the bias.



Instructions given to patient :

•Brush twice a day

•All patients will be instructed not to use any chemical plaque control method.



Sample collection :  Dental floss will be cleaned with a recombigen swab and plaque sample will be collected after 21 days of bonding from the cervical area of tooth and some amount of plaque will be scraped with a scaler and stored in a saline containing test tube and will be sent for microbiology test in Genexis Biotech Pvt. Ltd. Lab.





•To check the Antimicrobial activity, plaque sample collected on 21st day will be inoculated in Luria Broth for isolation of  S.mutans and Lactobacillus acidophilus.   Grown culture will be used for serial dilution, plated on chrome agar plates for specific identification of  bacterial growth. The different colour colonies will be further inoculated in Luria Broth and incubate overnight at 37°C for growth.  Bacterial isolate will be used for genomic DNA extraction, G DNA will be isolated using Genomic DNA extraction kit, followed by 16srdna using universal primers for 16srDNA,  PCR samples will be confirmed on (0.8%) agarose gel electrophoresis. PCR sample will be purified using PCR clean up kit. PCR cleanup product will be sent for sequencing.  Protocol used for pcr amplification will be followed accordingly. Thermocycle conditions are 94°C for 3 minutes,  94°C for 45 seconds,  50°C for 60 seconds,  72°C for 90 seconds,  Repeat steps 2-4 35 times,  72°C for 10 minutes, 4°C HOLD

 

•For Results - Colony Forming Units (CFU) will be counted and antimicrobial property of orthodontic adhesive modified with silver nanoparticles will be compared with the adhesive without silver nanoparticles.

 

 
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