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CTRI Number  CTRI/2022/09/046022 [Registered on: 29/09/2022] Trial Registered Prospectively
Last Modified On: 07/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Analysis of Simvastatin (anti-cholesterol drug) gel in bone formation. 
Scientific Title of Study   A comparative evaluation of osseous regeneration in the surgical extraction socket of mandibular third molars using a semisolid simvastatin formulation vs PRF (Platelet Rich Fibrin) - A Split Mouth Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monika Gupta 
Designation  Professor 
Affiliation  Maharishi Markandeshwar (Deemed to be University) 
Address  Department of Oral and Maxillofacial Surgery Maharishi Markandeshwar College of Dental Sciences and Research Mullana Ambala
Department of Oral and Maxillofacial Surgery Maharishi Markandeshwar College of Dental Sciences and Research Mullana Ambala
Ambala
HARYANA
133207
India 
Phone  09888895374  
Fax    
Email  monikabox@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asish Mathew Joseph 
Designation  PG Resident 
Affiliation  Maharishi Markandeshwar Deemed to be University 
Address  Department of Oral and Maxillofacial Surgery Maharishi Markandeshwar College of Dental Sciences and Research Mullana Ambala Haryana
Department of Oral and Maxillofacial Surgery Maharishi Markandeshwar College of Dental Sciences and Research Mullana Ambala Haryana
Ambala
HARYANA
133207
India 
Phone  9380404367  
Fax    
Email  asishmjoseph@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tulshi Chakraborty 
Designation  Associate Professor & Head of the Department of Pharmaceutics 
Affiliation  Moulana Abul Kalam Azad Technical University 
Address  Bengal College of Pharmaceutical Sciences and Research Moulana Abul Kalam Azad Technical University Kolkata West Bengal
Bengal College of Pharmaceutical Sciences and Research Moulana Abul Kalam Azad Technical University Kolkata West Bengal
Barddhaman
WEST BENGAL
700064
India 
Phone  7357438121  
Fax    
Email  tuldiotulshi@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral and Maxillofacial Surgery Maharishi Markandeshwar College of Dental Sciences and Research Mullana Ambala 
 
Primary Sponsor  
Name  Dr Monika Gupta 
Address  Maharishi Markandeshwar College of Dental sciences and Research Mullana, Ambala, Haryana 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Asish Mathew Joseph  Chirakkarottu House Vadavathoor PO Kottayam 10 Kerala 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Monika Gupta  Maharishi Markandeshwar College of Dental Sciences and Research  Department of Oral and Maxillofacial Surgery Room No-2 Maharishi Markandeshwar College of Dental Sciences MMDU Mullana Ambala
Ambala
HARYANA 		 09888895374

monikabox@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC MAHARISHI MARKANDESHWAR INSTITUTE OF MEDICAL SCIENCES AND RESEARCH MULLANA AMBALA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Platelet Rich Fibrin (PRF)  Autologous Blood Concentrate Product will be placed in empty bony socket after extraction of impacted 3rd molar once only Duration of intervention: 1 hour 
Intervention  Sterile Semisolid Simvastatin Formulation  Anti-cholesterol drug simvastatin (10mg/ml) will be placed as semisolid carrier made up of oleic acid, PEG-400, TWEEN-80 along with simvastatin salt in the empty bony socket once only. Duration of intervention: 1 hour  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Surgical site should be free of infection.

Patient requiring extraction bilaterally of impacted mandibular third molars.

The site should be where primary wound closure can be achieved.
 
 
ExclusionCriteria 
Details  Patient having connective tissue/bleeding disorders.

Patient who have undergone radiation/chemotherapy to head and neck region.

Patients allergic to drug simvastatin.

Patient having uncontrolled diseases of systemic nature.

Patients with fibro-osseous diseases of bone.

Any pathology associated with apical region of mandibular third molar.

Patients on immuno-supressants and/or on anticoagulants. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the bone height, bone volume, bone mineral density and trabecular pattern in the empty surgical extraction socket where simvastatin/PRF (Platelet Rich Fibrin) is placed, via CBCT analysis.   CBCT analysis to be done-
of bony socket before placement of Simvastatin/PRF immediately after surgical extraction of third molars (baseline).
6th month post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate pain at follow-up.  1st week, 3rd week, 3rd month and at 6th month. 
To measure swelling at follow-up.  1st week, 3rd week, 3rd month and at 6th month. 
To assess the probing depth distal to the second molar.   1st week, 3rd week, 3rd month and at 6th month. 
To observe for trismus.  1st week, 3rd week, 3rd month and at 6th 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)   01/10/2022 
Date of Study Completion (India) 01/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [asishmjoseph@gmail.com].

  6. For how long will this data be available start date provided 01-09-2023 and end date provided 19-08-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a randomized controlled trial (flip of coin), interventional split mouth study to compare the quality and quantity of osseous regenerate in the bony surgical extraction sockets of bilaterally impacted third molars, using Simvastatin Semi-solid gel formulation versus PRF. The primary objective of the study is to determine bone mineral density, bone volume, bone height and trabecular pattern of regenerate, via CBCT analysis. 
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