| CTRI Number |
CTRI/2025/06/089135 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision ofSilver nanoparticles with Platelet Rich fibrin vs bone graft with Platelet rich fibrin by observing clinical healing and bone fill in intrabony defect of gums |
|
Scientific Title of Study
|
Comparative Evaluation of Silver Nano Particles with PRF Vs PRF With Xenograft In Two-Walled Intra-bony Defects: A Clinico-Radiographic 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 Samruddhi Sunil Thakare |
| Designation |
MDS-1 |
| Affiliation |
SMBT IDSR, DHAMANGAON, NASHIK |
| Address |
Department of Periodontology and Oral Implantology,SMBT IDSR,DHAMANGAON, NASHIK
Nashik
MAHARASHTRA
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8108148018 |
| Fax |
|
| Email |
samruddhithakare910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kshitij Pardeshi |
| Designation |
Reader |
| Affiliation |
SMBT IDSR, DHAMANGAON, NASHIK |
| Address |
Department of Periodontology and Oral Implantology ,SMBT IDSR,DHAMANGAON, NASHIK
Nashik
MAHARASHTRA
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
7507712339 |
| Fax |
|
| Email |
seekvp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samruddhi Sunil Thakare |
| Designation |
MDS-1 |
| Affiliation |
SMBT IDSR, DHAMANGAON, NASHIK |
| Address |
Departmnt of Periodontolgy and Oral Implantology, SMBT IDSR,DHAMANGAON, NASHIK
Nashik
MAHARASHTRA
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8108148018 |
| Fax |
|
| Email |
samruddhithakare910@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Samruddhi Sunil Thakare |
| Address |
Department of Periodontology and Oral Implantology, SMBT IDSR, DHAMANGAON NASHIK |
| 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 Samruddhi Sunil Thakare |
DEPARTMENT OF PERIODONTOLOGY |
DEPARTMENT OF PERIODONTOLOGY and Oral Implantology, SMBT IDSR,
DHAMANGAON
NASHIK
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
8108148018
samruddhithakare910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OD SMBT IDSR,DHAMANGAON,GHOTI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
silver nanoparticles (20-30nm) |
silver nanoparticles with PRF on Two-walled intra-bony defect by Open flap debridement |
| Comparator Agent |
Xenograft |
Xenograft with PRF on Two-walled intra-bony defect by Open flap debridement |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Periodontitis Within 25 to 55 Years of Age
Probing Pocket Depth more than 5 Mm
Evidence Of two-walled Angular defects as determined by intraoral periapical radiograph |
|
| ExclusionCriteria |
| Details |
Undergoing Anti – coagulant therapy
Systemic Conditions such as Myocardial Infarction, Stroke, Renal diseases, Carcinoma etc In the Past 6 Months
Adverse Habit such as Tobacco consumption & Smokers
Pregnant & Lactating Women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiographic Depth of Intra bony Defect |
at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in Clinical Attachment Level Probing depth |
2 weeks, 4 weeks, 3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Platelet rich fibrin with bone graft is routinely used as regenerative material in Periodontology for augmentation of lost bone. Silver nanoparticles are used for medical purposes in wound dressisngs, ointments and orthopedic implants and silver impregnated sutures. Silver nanoparticles have wound healing properties as well as potential osteogenic properties aiding regeneration of of bone. The patients meeting the inclusion criteria will be evaluated and alloted in Group A : PRF with AgNPs Group B : PRF with xenograft Open Flap debridement of both groups will be done and placement of designated material will be placed in the defect followed by closure with sutures. Pre and Post operative evaluation of Probing depth, Clinical Attachment level and radiographic bone depth is compared along with healing of soft tissue. |