| CTRI Number |
CTRI/2024/10/074804 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study compares two treatments for healing after tooth extraction one uses a gel foam with a drug called Simvastatin and the other uses a substance made from patients own blood called Platelet-Rich Fibrin |
|
Scientific Title of Study
|
Comparison of the effect of Simvastatin impregnated gel foam and Platelet rich Fibrin on post-operative outcomes in patients undergoing extraction of mandibular molars |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SALONI KANABAR |
| Designation |
PG student |
| Affiliation |
sharad pawar dental college |
| Address |
Room number 4 department of oral and maxillofacial surgery sharad pawar dental college and hospital sawangi wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9979899525 |
| Fax |
|
| Email |
salonikanabar4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DEEPANKAR SHUKLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
sharad pawar dental college |
| Address |
Room number 4 department of oral and maxillofacial surgery sharad pawar dental college and hospital sawangi wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9925534891 |
| Fax |
|
| Email |
dr.deepankarshukla@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SALON I KANABAR |
| Designation |
PG RESIDENT |
| Affiliation |
sharad pawar dental college |
| Address |
Room number 4 department of oral and maxillofacial surgery sharad pawar dental college and hospital sawangi wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9979899525 |
| Fax |
|
| Email |
salonikanabar4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Sawangi, Meghe, Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 SALONI KANABAR |
SHARAD PAWAR DENTAL COLLEGE AND HOSPITAL |
ROOM NUMBER 4, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY Wardha MAHARASHTRA |
9979899525
salonikanabar4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute Of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet Rich fibrin |
Extraction of mandibular molars followed by inserting Platelet Rich Fibrin into the extraction socket to evaluate bone regeneration and soft tissue healing after 3 months and 6 months |
| Comparator Agent |
Simvastatin impregnated gel foam |
Extraction of mandibular molars followed by inserting Simvastatin impregnated gel foam into the extraction socket to evaluate bone regeneration and soft tissue healing after 3 months and 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with ASA Grade I status.
2 Patients between 16-50 years of age undergoing extraction of mandibular molars.
3 Patients indicated for extraction of mandibular molars.
4 Patient willing to participate, draw blood sample. |
|
| ExclusionCriteria |
| Details |
Patients with hypertension, diabetes mellitus or any other co morbidities. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Simvastatin is better compared to Platelet Rich Fibrin in terms of Bone regeneration and soft tissue healing. |
Sft tissue healing seen on post operative day 2 an day 8. Bone regeneration seen post operatively after 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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="3" Months="0" 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
|
Background Residual ridge resorption (RRR), which occurs after tooth extraction, is a chronic, continuous, irreversible, and accumulative type of bone resorption. Because of the continued resorption of alveolar bone, this causes multiple cosmetic and functional challenges in individuals who have missing teeth. Consequently, in order to maintain the existing alveolar ridge, a great deal of research has been conducted on methods to stop the loss of alveolar bone or encourage the development of new bone. In view of this, a study will be conducted to assess and compare the effectiveness of PRF and Simvastatin in terms of their ability to promote bone regeneration and their ability to repair wounds in the extraction socket of mandibular molars. Objectives • To evaluate the effects of Simvastatin-impregnated gel foam on regeneration of bone and wound healing in patients undergoing mandibular molar extractions against those using PRF. Methods Procedure will be performed in patients undergoing extraction of mandibular molars. Patients will be divided in 2 groups. Immediately after the extraction, In Group 1, extraction sockets will receive Gel Foam as a carrier for the medication Simvastatin (10 mg, crushed and dispersed into normal saline); in Group 2, PRF will be grafted. Expected results For individuals having their mandibular molars extracted, gel foams infused with simvastatin will promote improved wound healing and bone regeneration. Conclusion It is hypothesized that Simvastatin impregnated gel foam placed might give better results.In patients having mandibular molar extraction, if Simvastatin Impregnated Gel foam is shown to be superior to PRF in regard to regeneration of bones and wound healing, it will overcome the disadvantage related to PRF i.e, collection of blood via Phlebotomy, cost of Centrifuge machine used to make PRF. |