| 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
|
|
|
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
|
|
|
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. |