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CTRI Number  CTRI/2024/08/073006 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Simvastatin Enhanced Titanium prepared platelet rich fibrin Scaffold and Standard Titanium prepared platelet rich scaffold on Bone changes Around Implants 
Scientific Title of Study   Efficacy of Titanium prepared Platelet rich fibrin(T-PRF) scaffold loaded with Simvastatin versus Titanium prepared Platelet rich fibrin(T-PRF) on peri implant bone changes a randomized controlled clinical 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 Uma S 
Designation  PG Student 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Room no: 7, Second floor, Department of Periodontology, Meenakshi Ammal Dental college and Hospital, Alapakkam Main Road, Maduravoyal, Chennai.

Chennai
TAMIL NADU
600095
India 
Phone  8056029914  
Fax    
Email  dr.umasiva@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Vijayalakshmi R 
Designation  Professor 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Room No:7,Second floor, Department of Periodontology, Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Maduravoyal, Chennai.

Chennai
TAMIL NADU
600095
India 
Phone  9444765440  
Fax    
Email  rajaramvijayalakshmi@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Uma S 
Designation  PG Student 
Affiliation  Meenakshi Ammal Dental College and Hospital 
Address  Room No:7, Second floor, Department of Periodontology, Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Maduravoyal, Chennai.

Chennai
TAMIL NADU
600095
India 
Phone  8056029914  
Fax    
Email  dr.umasiva@gmail.com  
 
Source of Monetary or Material Support  
Meenakshi Ammal Dental College and Hospital, Alapakkam main road, Maduravoyal, Chennai-95 
 
Primary Sponsor  
Name  Meenakshi Ammal Dental College and Hospital 
Address  Alapakkam Road, Maduravoyal, Chennai-600095 
Type of Sponsor  Research institution and hospital 
 
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 UMA S  Meenakshi Ammal Dental College and Hospital  Room No: 7, Second floor, Department of Periodontology, Meenakshi Ammal Dental college and Hospital, Alapakkam main road, Maduravoyal, Chennai - 600095
Chennai
TAMIL NADU 		 8056029914

dr.umasiva@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee Meenakshi Ammal Dental college and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Simvastatin loaded in Titanium prepared platelet rich fibrin  Titanium prepared platelet rich fibrin is loaded with simvastatin 1.2mg and placed in osteotomy site for implant placement for 6 months 
Comparator Agent  Titanium prepared platelet rich fibrin   Titanium prepared platelet rich fibrin is placed in osteotomy site for implant placements for 6 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Systemically healthy patients.
Partially edentulous patient with missing posterior teeth. 
 
ExclusionCriteria 
Details  Patients who are pregnant and lactating.
Patients with history of bone metabolic disease.
Patients currently taking drug that can influence bone metabolism.
Use of bisphosphonates in last 4 years.
Patients who are smokers.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Peri implant bone changes   Day 0(The day of implant placement) and at 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
Mean crestal bone changes after implant loading  At 12th month 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/09/2024 
Date of Study Completion (India) 12/03/2025 
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 Applicable 
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   The aim of the study is to compare the efficacy of Titanium-prepared Platelet rich Fibrin (T-PRF) scaffold loaded with Simvastatin and Titanium-prepared Platelet rich Fibrin alone on periimplant bone changes in patients undergoing implant placement using randomized control trial method. 16 systemically healthy patients will be randomly selected and 8 patients will be allotted to Group-A and remaining 8 will be allotted to Group-B. Group-A patients will receive T-PRF scaffold loaded with 1.2 mg Simvastatin in the osteotomy site during implant placement and Group-B patients will receive T-PRF scaffold alone during implant placement. CBCT will be taken for all the patients on Day-0 and at 6 months to assess the peri-implant bone changes. 
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