| CTRI Number |
CTRI/2012/11/003086 [Registered on: 06/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
19/10/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of platelet rich fibrin (PRF) in formation of tooth apex in cases of immature front teeth |
|
Scientific Title of Study
|
To evaluate and compare apexogenesis induced by revascularization,with and without platelet-rich fibrin (PRF) in non-vital, immature anterior teeth – a pilot clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1135-2417 |
UTN |
| IESC/T-202/01.06.2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Bansal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Third floor Department of Conservative Dentistry and Endodontics Centre for Dental Education and Research All India Institute of Medical Sciences New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8585902602 |
| Fax |
|
| Email |
dr_nik_bansal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naseem Shah |
| Designation |
Chief |
| Affiliation |
AIIMS |
| Address |
Centre for Dental Education and Research All India Institute of Medical Sciences New Delhi
New Delhi
DELHI
110029
India |
| Phone |
01126589304 |
| Fax |
01126589304 |
| Email |
naseemys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naseem Shah |
| Designation |
Chief |
| Affiliation |
AIIMS |
| Address |
Centre for Dental Education and Research All India Institute of Medical Sciences New Delhi
DELHI
110029
India |
| Phone |
01126589304 |
| Fax |
01126589304 |
| Email |
naseemys@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Science |
| Address |
Ansari Nagar New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nikhil Bansal |
Department of Conservative Dentistry and Endodontics Centre for Dental Education and Research |
Centre for Dental Education and Research All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI |
8585902602
dr_nik_bansal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Non-vital open apex immature anterior permanent teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Apexogenesis with blood clot |
Only bleeding is induced into the canal by overinstrumentation and additional PRF is not placed in the canal |
| Intervention |
Apexogenesis with platelet rich fibrin |
After control of intra canal infection by chemomechanical means indigenous stem cells residing in the periapical area of teeth being treated are stimulated by intentional overinstrumentation beyond the apical foramen and platelet rich fibrin prepared from patients blood be placed inside the canal |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A)Patients having anterior maxillary non-vital, immature teeth with open apex with or without radiographic evidence of periapical lesion.
B)Healthy patients with no systemic disorder
|
|
| ExclusionCriteria |
| Details |
Systemic conditions that limit the invasive procedures and which can compromise the healing response |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete control and resolution of clinical signs and symptoms such as pain, swelling, inflammation and restoration of function. Radiographic evidence of healing of periapical lesions showing disappearance or reduction in size of the lesion. Radiographic evaluation of dentinal wall thickening and elongation of root
|
Follow up at 3,6 9,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Seal of mineralized tissue at the root apices showing periapical healing, root lengthening, thickening of lateral dentinal walls, apical closure |
Follow up at 3,6 9,12 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2012 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a pilot clinical study for treatment of cases presenting immature anterior permanent teeth. After control of intra canal infection by chemo-mechanical means, indigenous stem cells residing in the periapical area of teeth being treated are stimulated by intentional over-instrumentation beyond the apical foramen and platelet rich fibrin prepared from patients blood be placed inside the canal and coronal restoration is placed to prevent micro-leakage and future reinfection |