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CTRI Number  CTRI/2025/02/080624 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluating the Effect of Silver Nanoparticles Derived from Herbal Plant Arjuna as Photocatalyst in Photodynamic Therapy along with Scaling in Patients with Chronic Gum Disease. 
Scientific Title of Study   Clinical Evaluation of Effectiveness of Silver Nanoparticles Derived from Terminalia Arjuna Plant Extract as Photocatalyst in Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Management of Chronic Periodontitis – A Randomized Control 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  Dr Priyanka Dalvi 
Designation  Second Year Post Graduate MDS, Department of Periodontics 
Affiliation  Nair Hospital Dental College, Mumbai 
Address  Room no.201,Department of Periodontics Nair Hospital Dental College, Mumbai, Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  7039035186  
Fax    
Email  dalvipriyanka3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mala Dixit Baburaj 
Designation  Professor and Head of the Department 
Affiliation  Nair Hospital Dental College, Mumbai 
Address  Room no.201,Department of Periodontics Nair Hospital Dental College, Mumbai, Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  9223340938  
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mala Dixit Baburaj 
Designation  Professor and Head of the Department 
Affiliation  Nair Hospital Dental College, Mumbai 
Address  Room no.201,Department of Periodontics Nair Hospital Dental College, Mumbai, Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  9223340938  
Fax    
Email  maladixit25@gmail.com  
 
Source of Monetary or Material Support  
Dr. Priyanka Dalvi, Room no.201,Department of Periodontics, Nair Hospital Dental College, Mumbai, Maharashtra, 400008 India 
 
Primary Sponsor  
Name  Dr. Priyanka Dalvi 
Address  Room no 13,A Wing, New Radhika CHS, Central Park, Nalasopara East, Palghar, Maharashtra, 401209 
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 Priyanka Dalvi  Nair Hospital Dental College, Mumbai  Room no 201, Department of Periodontics, Nair Hospital Dental College, Mumbai, Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India
Mumbai
MAHARASHTRA 
7039035186

dalvipriyanka3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Nair Hospital Dental College  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  Photodynamic Therapy  Photodynamic Therapy. The Total Duration of Intervention is 6 Months. 
Intervention  Silver Nanoparticles as Photocatalyst in Photodynamic therapy  Silver Nanoparticles Derived from Terminalia Arjuna Plant Extract as Photocatalyst in Photodynamic therapy. The Total Duration of Intervention is 6 Months. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) systemically healthy adult 25-50 years age group.
2)periodontal pockets greater than 3mm and less than 5mm deep.
2) Patients with chronic periodontitis
3) Patient willing to give the informed consent and willing to comply with the study were selected
 
 
ExclusionCriteria 
Details  1) Systemic diseases- active cancer, photodermatoses, photoallergies, encephalitis, meningitis, hyper/ hypo thyroidism.
2) Pregnancy.
3) Smoking
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Plaque Index (P.I.)
(Silness and Loe)
2. Gingival Index (G.I.) (Loe and Silness, 1963)
3. Probing Pocket Depth (PPD)
4. Clinical Attachment Level (CAL) 
1) At Baseline
2) After 1 month
3) After 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. Plaque Index (P.I.)
(Silness and Loe)
2. Gingival Index (G.I.) (Loe and Silness, 1963)
3. Probing Pocket Depth (PPD)
4. Clinical Attachment Level (CAL) 
1) At Baseline
2) After 1 month
3) After 3 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/03/2025 
Date of Study Completion (India) 01/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/09/2025 
Estimated Duration of Trial   Years="0"
Months="6"
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   Aims and Objective:
To clinically evaluate the effectiveness Silver nanoparticles derived from Terminalia Arjuna plant extract as photocatalyst in photodynamic therapy as an adjunct to Scaling and Root Planing in chronic periodontitis patient by Evaluation of plaque index, gingival index, probing pocket depth and clinical attachment loss.

Introduction:
Periodontitis is an inflammatory disease of the gums that destroys the foundation on which teeth rest. Deterioration of periodontal ligaments (PDLs), the development of periodontal pockets, and the resorption of alveolar bone are hallmarks. Photodynamic therapy (PDT) is a form of phototherapy involving photochemistry, photophysics, and photobiology. In the past few years, therapeutic nanoparticles (NPs), as a developing engineering solution for treating periodontitis, have received extensive attention. NPs possess distinct therapeutic qualities, including exceptional antibacterial, anti-inflammatory, and antioxidant properties, immunomodulatory capacities, and the promotion of bone regeneration ability. Silver NPs (AgNPs) with a size of less than 100 nm and a uniform spherical shape have high and broad-spectrum antimicrobial activity.
The purpose of this study is to Clinically Evaluate the Effectiveness of Silver Nanoparticles derived from Terminalia Arjuna plant extract as Photocatalyst in Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Management of Chronic Periodontitis – A Randomized Control Trial”

Material and Methods:

The patients fulfilling the inclusion criteria will be divided into two groups using Computer assisted randomization – Group A and Group B

A) Group A: Scaling and Root Planing (SRP) with photodynamic therapy

B) Group B: Scaling and Root planing (SRP) with Photodynamic therapy with silver nanoparticles derived from Terminalia Arjuna plant extract.

Scaling and Root planing (SRP) will be done using Ultrasonic Scaler

Procedure:

Following initial examination and treatment planning, the subjects will be divided into Groups A and B. The baseline details of Gingival, Plaque, Pocket Probing depth, Clinical Attachment level will be noted. After initial examination both the groups will be treated by scaling and root planning followed by photodynamic therapy.

Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software.

Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.  

For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non parametric substitute like Mann Whitney U test will be used.

Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test.

Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used.

Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant. 

 
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