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CTRI Number  CTRI/2019/04/018718 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 18/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Use of silver nanoparticles for the treatment of pyorrhea 
Scientific Title of Study   The Clinical and Anti-inflammatory action of Silver Nanoparticles in the treatment of Chronic Periodontitis 
Trial Acronym  CASN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ishita Joshi 
Designation  Junior Resident 
Affiliation  King George Medical University 
Address  Department of periodontology Faculty of Dental Science King George Medical University Shahmina Road, Chowk

Lucknow
UTTAR PRADESH
26003
India 
Phone  851928717  
Fax    
Email  ijoshi7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Kaushal 
Designation  Professor 
Affiliation  King George Medical University 
Address  Department of periodontology Faculty of Dental Science King George Medical University Shahmina Road, Chowk

Lucknow
UTTAR PRADESH
26003
India 
Phone  9450454408  
Fax    
Email  shalinikaushal@kgmcindia.edu  
 
Details of Contact Person
Public Query  
Name  Ishita Joshi 
Designation  Junior Resident 
Affiliation  King George Medical University 
Address  Department of periodontology Faculty of Dental Science King George Medical University Shahmina Road, Chowk

Lucknow
UTTAR PRADESH
26003
India 
Phone  851928717  
Fax    
Email  ijoshi7@gmail.com  
 
Source of Monetary or Material Support  
Research Cell, King George Medical University, Shahmina Road, Chowk-226003, Lucknow, Uttar Pradesh 
 
Primary Sponsor  
Name  Research Cell KGMU 
Address  King George Medical University Shahmina Road, Chowk-2226003 
Type of Sponsor  Government medical 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 
Dr Ishita Joshi  King George Medical University  Room No. 14, Department of Periodontology Faculty of Dental Sciences King George Medical University Shahmina Road, Chowk-226003
Lucknow
UTTAR PRADESH 		 8851928717

ijoshi7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Water Dose- 16 ml Frequency- approx. 4 ml once every week for 3 consecutive weeks Duration-3 weeks  
Intervention  Silver nanoparticles solution   Concentration- 0.01mg/ml Silver Nanoparticles Dose- 16 ml Method of application- Local drug delivery into the periodontal pocket Frequnecy- Approx. 4 ml once a week for 3 consecutive weeks Duration- 3 weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. 25-50 years of age

2. Probing pocket depth ≥ 5mm

3. Systemically healthy patients

4. No history of periodontal therapy in the last 6 months
 
 
ExclusionCriteria 
Details  1. Smokers
2. Pregnant or lactating women
3. Allergic to silver metal
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Use of Silver nanoparticles as an adjunct to scaling and root planing  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Use of Silver nanoparticles as an adjunct to scaling and root planing  3 months 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 
Date of First Enrollment (India)   30/04/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
25 patients with chronic periodontitis will be recruited for the study. A split mouth randomized study will be conducted where the drug will be given in one quadrant of the patient’s mouth along with scaling and root planning and the contralateral side will be treated with scaling and root planing along with pacebo. The patients will be selected in such a way that both sides of the mouth are equally affected by chronic periodontits.  The patient’s Gingival index, papillary bleeding index, probing pocket depth and clinical attachment gain will be recoreded at baseline, 1 month and then 3 months.
The patient’s gingival crevicular fluid will be collected at baseline,1 month and 3 months for its biochemical assay in order to assess the change in the level of interleukin 1 beta. The drug will be delivered in the periodontal pocket. This will be done in order to understand the clinical as well as the anti-inflammatory action of silver nanoparticles. If the outcome of the study will be positive it will be ascertained that Silver nanoparticles aid scaling and root planing in the treatment of chronic periodontitis.
 
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