| 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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with periapical pathology in maxillary and mandibular anterior teeth region., |
|
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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. |
|
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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.
|
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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. |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 |