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CTRI Number  CTRI/2017/08/009415 [Registered on: 18/08/2017] Trial Registered Retrospectively
Last Modified On: 18/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of healing after periapical surgery BY ULTRASOUND using platelet rich fibrin. 
Scientific Title of Study   Healing in surgical endodontics with and without the use of PRF: evaluated by color power doppler ultrasonography. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SANJEEV CHAUHAN 
Designation  Postgraduate student 
Affiliation  Himachal Pradesh Government Dental College and Hospital Shimla ,Himachal Pradesh . 
Address  Department of Conservative Dentistry and Endodontics,Himachal Pradesh Government Dental College and Hospital Shimla ,Himachal Pradesh
Neelam bhawan, Below Brainds and Bargain Sanjauli, Shimala Himachal Pradesh
Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418223501  
Fax  09418223501  
Email  sanjeev1231971@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashu Gupta 
Designation  Head of the Deptt. 
Affiliation  H.P.G.D.C. Shimla h.p. 
Address  Department of Conservative Dentistry and Endodontics,H.P. Govt. Dental College and Hospital Shimla , H.P. 171001
Department of Conservative Dentistry and Endodontics,H.P. Govt. Dental College and Hospital Shimla , H.P. 171001
Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418470020  
Fax    
Email  guptaashumoni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SANJEEV CHAUHAN 
Designation  Postgraduate student 
Affiliation  Himachal pradesh Government Dental College and Hospital Shimla h.p. 
Address  Department of Conservative Dentistry and Endodontics,H.P. Govt. Dental College and Hospital Shimla , H.P. 171001
Neelam Bhawan,Near Brands and Bargain, Sanjauli Shimla , H.P. 171006
Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418223501  
Fax  9418223501  
Email  sanjeev1231971@gmail.com  
 
Source of Monetary or Material Support  
sanjeev chauhan, Postgraduate student, Department of Conservative Dentistry and Endodontics, H.P. Govt. Dental College and Hospital Shimla ,Himachal Pradesh  
 
Primary Sponsor  
Name  Himachal Pradesh Government Dental College and Hospital Shimla  
Address  H.P. Govt. Dental College and Hospital Shimla , H.P. 171001 
Type of Sponsor  Other [Himachal Pradesh Government Dental College and Hospital Shimla , Himachal Pradesh] 
 
Details of Secondary Sponsor  
Name  Address 
sanjeev chauhan  H.P. Govt. Dental College and Hospital Shimla , H.P. 171001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjeev Chauhan   Himachal Pradesh Government Dental College and Hospital Shimla  Department of Conservative Dentistry and Endodontics,H.P. Govt. Dental College and Hospital Shimla , H.P. 171001
Shimla
HIMACHAL PRADESH 
9418223501
9418223501
sanjeev1231971@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE HP GDC SHIMLA HP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with periapical pathology in maxillary and mandibular anterior teeth region.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  platelet rich fibrin (prf)  Comparative evaluation of healing was done between the two groups using PRF in one group and without PRF in other group. 
Intervention  WITH PRF  IN ONE GROUP PRF WAS PLACED IN THE BONY DEFECT AFTER SURGICAL EXCISION OF THE LESION AND IN THE OTHER GROUP NO PRF WAS PLACED. HEALING WAS COMPARATIVELY STUDIED IN BOTH THE GROUPS POSTOPERATIVELY WITH COLOR POWER DOPPLER ULTRASONOGRAPHY AT 1,3 AND 6 MONTHS. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.The patients with no general medical contraindications for oral surgical procedures. 2.The patients with only maxillary and mandibular anterior teeth that required periradicular surgery. 3.The minimum diameter of the bone defect, as determined from periapical radiographs, to be at least 6 mm. 4.The nonsurgical re-treatment is judged unfeasible or had previously failed. 5.The apical root canal to be devoid of the presence of a post for at least 6 mm. 6. No spontaneous pain or swelling should have been present. 
 
ExclusionCriteria 
Details  presence of any kind of pathosis associated with vertical root fracture; perforation of the furcation area or lateral canal walls; moderate to severe periodontal bone loss, detected with a periodontal probe (probing depth greater than 5 mm). Patients with neuropsychiatric disorders were also be excluded. Any general condition of patient contraindicated for surgical treatment under local anaesthesia. Age less than 21 yrs and more than 35 years were also excluded.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Platelet rich fibrin showed better healing of the surgical defect then the non platelet rich fibringroup.  Healing in Platelet rich fibrin group was better then the non platelet rich fibrin group at 1,3 and 9 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in healing was not significant at 1 month but the difference was significant at 3 and 6 months.  Significant difference in healing at 3 and 6 months. 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/01/2015 
Date of Study Completion (India) 26/09/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NO PUBLICATION TILL DATE 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Platelet-rich fibrin (PRF) belongs to a new generation of platelet concentrates, with simplified processing and without biochemical blood handling. PRF, as a physiologic fibrin matrix, serves as a net to stem cells, especially when an accelerated angiogenesis develops in the fibrin membrane .This aspect is of particular interest in the case of wide osseous defects.Ultrasound imaging is an easy and reproducible technique that has the potential to supplement CR or DR in the diagnosis of periapical lesions. Ultrasound as a diagnostic tool has been widely used in many medical fields, and its applications in dentistry have not been sufficiently explored1.The present study was done to evaluate healing after periapical surgery using PRF in one group as an autologous scaffold to fill the bony cavity and leaving the cavity without scaffold in the other group and the healing was comparatively evaluating  by color power doppler ultrasonography after one, three and six months postoperatively. PRF used in this study was prepared using Choukroun’s technique. Choukroun’s platelet-rich fibrin (PRF) (David M. Dohan Ehrenfest 2010) is defined as an autologous leukocyte and platelet-rich fibrin (L-PRF) biomaterial. The PRF membranes release high quantities of growth factors (such as transforming growth factor TGFb-1, platelet-derived growth factor PDGF-AB or vascular endothelial growth factor VEGF) and matrix proteins (such as thrombospondin-1, fibronectin, vitronectin). In all the clinical applications, PRF has to be considered and used as a fibrin-based living biomaterial, and not only as a simple source of growth factors.26

             
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