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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  
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 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  
Status 
Not Applicable 
 
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.

 
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