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CTRI Number  CTRI/2025/04/084299 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 06/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study on Bone Healing After Tooth Extraction 
Scientific Title of Study   To Assess the Bone Regeneration in extraction sockets using Simvastatin in comparison to Rosuvastatin : 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 Chinmoy sanjay punalekar 
Designation  post graduate student 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010 
Address  OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  08605840858  
Fax    
Email  chinmoypunalekar460@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vijaylaxmi Shettar 
Designation  Professor 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010 
Address  OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi Belgaum KARNATAKA 590010 India KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  07349570643  
Fax    
Email  vijaylaxmi.s.2245@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vijaylaxmi Shettar 
Designation  Professor 
Affiliation  KLE VK INSTITUTE OF DENTAL SCIENCES , KAHER , BELAGAVI, KARNATAKA - 590010 
Address  OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  07349570643  
Fax    
Email  vijaylaxmi.s.2245@gmail.com  
 
Source of Monetary or Material Support  
Karnataka lingayat education society s Vishwanath katti dental college and hospital. 
 
Primary Sponsor  
Name  Dr. Chinmoy punalekar 
Address  Karnataka lingayat education society,s Vishwanath katti dental college and hospital-OPD number 5, belagavi 
Type of Sponsor  Other [Self funded] 
 
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 Vijaylaxmi Shettar  Karnataka lingayat education society s Vishwanath katti dental college and hospital   OPD number 5, OMFS Department,Karnataka lingayat education society,s Vishwanath katti dental college and hospital, nehrunagar, belagavi Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA 
07349570643

vijaylaxmi.s.2245@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS AND RESEARCH COMMITTEE KLE VKIDS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rosuvastatin 20 mg  rosuvastatin is drug which acts on the HMG Co A reductase enzyme and leads to decrease in the cholesterol levels. it also has shown pleiotrophic activity of bone formation. 
Comparator Agent  Simvastatin 10 mg  Simvastatin is drug which acts on the HMG Co A reductase enzyme and leads to decrease in the cholesterol levels. it also has shown pleiotrophic activity of bone formation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  Patients between 18 to 65 years requiring tooth extraction
Patients willing to give informed and written consent
 
 
ExclusionCriteria 
Details  • Patients who are medically compromised
• Patients allergic to drug.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Bone density, Bone width , Bone height measured on the cone beam computed tomography of the extracted socket  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
post operative pain using visual analog score scale.  7 days 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/04/2025 
Date of Study Completion (India) 12/04/2025 
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)   Not Yet Recruiting 
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     

·        Tooth loss affects the quality of life as it leads to ineffective mastication ,altered speech, concern about the appearance ,  loss of self confidence.

·        Partial or complete edentulism leads to bone resorption making rehabilitation difficult.

·        Following tooth extraction ,Several  Interventions that involve autografts, allografts, xenografts, guided bone regeneration (GBR) and growth factors have been used with varying degrees of success in an effort to maintain the anatomical dimensions of the alveolus before implantation.

·        Although autograft is considered gold standard there is risk of donor site morbidity , pain , infection , scarring , etc.

·        Commonly used  xenograft have higher risk of the immunological reaction and  infection, etc.

·        There is a constant search for the ideal graft material

·        Mundy G et al (1999) examined several compounds and found that Statin drugs like simvastatin used for lowering serum cholesterol increased the expression of bone morphogenetic protein-2 (BMP-2) gene in bone cells which leads to bone formation.

·        Rosuvastatin is a 2nd generation , hydrophilic stain which has demonstrated bone regeneration properties in furcation defects: hence the aim of this  study is to assess efficacy of Simvastatin and Rosuvastatin in regeneration of the bone after the extraction of the teeth.

 
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