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CTRI Number  CTRI/2020/08/026976 [Registered on: 04/08/2020] Trial Registered Prospectively
Last Modified On: 24/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of different bone graft materials around dental implants in fresh extraction sockets 
Scientific Title of Study   Effect of Simvastatin-Platelet Rich Fibrin (PRF) Combination Vs PRF and Allograft Combination Vs PRF Alone as Peri-Implant Gap Filling Graft Materials around Immediate Implants on Vertical Bone Implant Contact and Implant Stability: A Pilot Randomized Clinical Study 
Trial Acronym  PRF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gunjan Pruthi 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Division of Prosthodontics, OHSC, Sector 12, PGIMER
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9999968841  
Fax    
Email  gunjan_prostho@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Gunjan Pruthi 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Division of Prosthodontics, OHSC, Sector 12, PGIMER
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9999968841  
Fax    
Email  gunjan_prostho@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Gunjan Pruthi 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Division of Prosthodontics, OHSC, Sector 12, PGIMER
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9999968841  
Fax    
Email  gunjan_prostho@yahoo.co.in  
 
Source of Monetary or Material Support  
ICMR, New Delhi 
 
Primary Sponsor  
Name  ICMR 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 
Gunjan Pruthi  OHSC, PGIMER  Sector 12
Chandigarh
CHANDIGARH 
9999968841

gunjan_prostho@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post graduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with upper anterior teeth indicated for extraction 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Alloplast bone graft material  Alloplast bone graft material will be placed in periimplant gap after placement of implant 
Intervention  L-PRF  L-pRF membrane will be placed in periimplant gap around implant 
Intervention  Simvastatin gel in perimplant gap  Simvastatin gel will be prepared and placed in peri implant gap after placement of dental implant.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients with good systemic general and periodontal health, irrespective of sex and having age between 18-45 years
2. Patients in need of anterior single tooth extraction (maxillary incisors, canines, or premolars) because of any indication like failed endodontics, poor prognosis of repeat RCT, trauma, mobility, root fracture etc
3. Perimplant gap ≥ 2mm
4. Willing for participation in study, giving written informed consent and follow up
 
 
ExclusionCriteria 
Details  1. Patients with parafunctional habits, history of smoking, diabetes, any other systemic health problem, immuno compromised state, or pregnant females.
2. Symptomatic periapical lesions, acute abscesses, or sinus tracts in relation to tooth in question or adjacent teeth
3. Secondary exclusion criterion kept will be peri implant gap of more than 5mm
4. Primary stability of less than 35 N/cm.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Vertical bone to implant contact (BIC) on labial side of implant on cone beam CT and on mesial and distal sides on IOPA   Vertical bone to implant contact (BIC) on labial side of implant on cone beam CT and on mesial and distal sides on IOPA immediately after surgery, 6 months after surgery and one year. CBCT immediately and one year after surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome variable (SOV): Implant stability (Implant stability quotient values measured on Radio frequency analyser)  SOV will be measured at baseline, at 3 months and at one year. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 1 
Date of First Enrollment (India)   01/09/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet related to this subject.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Dental implants are placed in oral cavity to replace missing teeth. If they are placed in fresh extraction sockets, they are called as “Immediate implants”. To promote the bone formation around implants and to hasten healing, we need to put some graft material in the gap present between the socket walls and the implant. These graft materials can be artificial bone derived from different sources or platelet rich fibrin derived from patient’s own blood. Recently Simvastatin (medicine used for patients with heart related problems) has been used in animals and humans to promote bone formation. In this study, it will be prepared in form of gel in department of Pharmacology and its effect will be assessed on bone formation around implants and if there is any improvement in stability of implants in one year time period. For that, 36 patients with poor prognosis of upper front teeth will be enrolled. Tooth will be extracted followed by implant placement and grafting with one of the graft materials. Artificial crown will be fabricated over implant after 3 months and patients will be kept on follow up till one year after implant placement. Bone formation will be measured on radiographs two times (just after implant placement and at one year) and stability of implants will be measured three times ((just after implant placement, at 3 months and at one year). If we find good results, Simvastatin can be used in multiple clinical scenarios to promote bone formation.


 
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