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CTRI Number  CTRI/2018/07/014743 [Registered on: 05/07/2018] Trial Registered Retrospectively
Last Modified On: 04/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To determine the efficacy of Calcium Hydroxide And Silver Nanoparticles against miroorganisms during root canal treatment 
Scientific Title of Study   Comparative Evaluation Of Antimicrobial Activity Of Calcium Hydroxide And Silver Nanoparticles as Intracanal Medicament - An In vivo Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Kohli 
Designation  PG student 
Affiliation  Sudha Rustagi Dental College 
Address  Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics, Sudha Rustagi Dental College, Faridabad

Faridabad
HARYANA
121002
India 
Phone  9711220258  
Fax    
Email  aditikohli321@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Monika Tandan 
Designation  Professor 
Affiliation  Sudha Rustagi Dental College 
Address  Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics, Sudha Rustagi Dental College, Faridabad

Faridabad
HARYANA
121002
India 
Phone  9999063631  
Fax    
Email  drmonikatandan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aditi Kohli 
Designation  Post Graduate Student 
Affiliation  Sudha Rustagi Dental College 
Address  Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics, Sudha Rustagi Dental College, Faridabad

Faridabad
HARYANA
121002
India 
Phone  9711220258  
Fax    
Email  aditikohli321@gmail.com  
 
Source of Monetary or Material Support  
Sudha Rustagi Dental College,sector 89, kheri More, Faridabad 
 
Primary Sponsor  
Name  Sudha Rustagi Dental College 
Address  Sector 29, Kheri More, Faridabad, Haryana 
Type of Sponsor  Other [Private Dental College] 
 
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 
Rakesh Kumar  Sudha rustagi dental college  Room no. 7, 2nd floor, Department of conservative dentistry and endodontics, Sudha rustagi dental college
Faridabad
HARYANA 
9813172742

mttlrksh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, SRCDSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  calcium hydroxide powder  40 mg Calcium hydroxide powder was mixed with a drops of propylene glycol and applied to the root canal walls with lenturospiral and kept in the canal for 7 days. 
Intervention  intracanal medicament  it was used to disinfect the root canals in between appointments. 
Comparator Agent  Silver Nanoparticle dispersion, Nano Labs, India  Silver Nanoparticle dispersion was applied with paper point soaked in it and placed into the root canal for 7 days. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients with non-contributory medical history, intact permanent teeth without any previous restoration, with a necrotic or infected pulp as diagnosed clinically and radiographically, with adequate coronal structure for proper isolation, temporization, and restoration were included 
 
ExclusionCriteria 
Details  Patients with systemic conditions, acute periapical abscess,retreatment cases, patients on antibiotic therapy within three months, teeth with calcified canals, sinus opening, immature apex, internal or external resorption or periodontal pockets>5mm and pregnant women were excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in bacterial counts  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Colony counts in different groups at stages S1, S2 and S3  6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2016 
Date of Study Completion (India) 23/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/06/2017 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The aim of the present study was to compare and evaluate the antibacterial efficacy of calcium hydroxide paste and silver nanoparticles in vivo. 
In the present study, thirty patients with thirty single rooted teeth were selected. Patients with non-contributory medical history, intact permanent teeth without any previous restoration, with a necrotic or infected pulp as diagnosed clinically and radiographically, with adequate coronal structure for proper isolation, temporization, and restoration will be included. After local anaesthesia administration and rubber dam placement access opening was made and sample S1 was taken (three samples) with paper point after injecting 5 ml normal saline solution. After working length determination and biomechanical preparation till size #40 K-file, post instrumentation sample S2 was collected in the same manner as S1. Then, it was sent to laboratory for processing within 2 hours. After second sampling, the canals were dried and medicaments were applied randomly among 30 patients (15 patients each) with lentulospiral and left in place for 7 days. After 7 days, following medicament  removal, sample S3 was taken. Microbiological samples (S1, S2, S3) were preincubated for 30 minutes and shaken vigorously in a vortex mixture for 60 seconds and then were plated on Brain heart infusion agar and colonies were counted after 24 hours using classic bacterial counting method. 
The results showed that there was significant reduction of bacterial count from stages S1 (after access opening) to S2 (after biomechanical preparation), and S3 (after medicament placement) in both the experimental groups (intracanal medicaments). The percentage reduction was better with Group 2 (silver nanoparticles), however, it was not statistically significant when compared to Group 1 (Calcium hydroxide). 
Within the limitations of this study, it can be concluded that silver nanoparticles showed significant antimicrobial activity and can be used as an effective root canal medicament as an alternative to calcium hydroxide dressing.
 
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