| CTRI Number |
CTRI/2024/07/069898 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the role of three different materials in permanent teeth with incomplete root formation in children |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical and Radiographic Outcomes of Three different Scaffolds in Regenerative Endodontic Treatment: A Randomised 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 Mousumi Goswami |
| Designation |
Professor and Head of Department |
| Affiliation |
ITS Dental College Hospital and Research Centre Greater noida |
| Address |
Room no 9
Department of pediatric and Preventive Dentistry
ITS Dental College Hospital and Research Centre
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
|
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya Saxena |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room no 9
Department of pediatric and Preventive Dentistry
ITS Dental College Hospital and Research Centre
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8527969884 |
| Fax |
|
| Email |
adisaxen85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Saxena |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital and Research Centre |
| Address |
Room no 9
Department of pediatric and Preventive Dentistry
ITS Dental College Hospital and Research Centre
Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
8527969884 |
| Fax |
|
| Email |
adisaxen85@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR
Indian Council of edical Research
V Ramalingaswami Bhawan
PO Box No 4911
Ansari Nagar
New Delhi-110029
India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research
V.Ramalingaswami Bhawan PO Box No 4911
Ansari Nagar
New Delhi
110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Mousumi Goswami |
ITS Dental College Hspital and Research Centre |
Room no 9 Department of Pediatric and Preventive Dentistry
ITS Dental College Hospital and Research Centre
47, Knowledge Park III
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8588854190
mousumi87goswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K004||Disturbances in tooth formation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concentrated Growth Factor (CGF) |
CGF wiLL be used as scaffold
Preparation of CGF:
• Two disposable 10 ml non-anticoagulant tubes and a centrifuge will be used.
• 10ml of intravenous blood sample from the patient will be obtained and placed in
centrifuge tubes without anticoagulants; accelerated for 30 seconds; centrifuged at
2700 rpm for 2 min, 2400 rpm for 4 min, 2700 rpm for 4 min, and 3000 rpm for 3
min; and decelerated for 36 secs to stop.
• At the end of the automated pre-programmed cycle, the centrifuge tube will
encompassa concoction of four different layers; the uppermost or the 1stlayer
contained serum, the 2ndlayer was composed of a fibrin buffy coat, the 3rdlayer
constituted the much needed growth factors, and lastly, the lowermost or the 4thlayer
was occupied by the red blood cells. CGF will be obtained by separating the fibrin gel
from the red blood cells. |
| Comparator Agent |
Platelet rich fibrin (PRF) |
PRF will be used as scaffold in Group A
Preparation of PRF:
• Two disposable 10 ml non-anticoagulant tubes and a centrifuge will be used.
• 10ml of intravenous blood sample from the patient will be obtained and placed in
centrifuge tubes without anticoagulants and centrifuges at 3000 rpm for 12 minutes.
• At the end of the cycle, PRF will be obtained by separating the fibrin clot from the red
blood cells.
|
| Intervention |
SynOss Putty |
SynOss Putty will be used as scaffold
It is in the form of foam that will be mixed with distilled water to form a gel like consistency |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children with non-vital immature permanent teeth requiring endodontic treatment
ASA I and II Patient
Compliant Patient and Parent |
|
| ExclusionCriteria |
| Details |
Post/core required for final restoration
Patient Allergic to any medicaments or antibiotics to be used during the procedure |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical outcomes
Resolution of signs and symptoms like pain, swelling, pus drainage, tooth
mobility
Tooth survival
Restoration of function
2. Radiographic outcomes
Resolution of periapical pathology |
Time intervals
At Baseline
1 Month Post Procedure
3 Months Post Procedure
6 Months Post Procedure
1 year Post Procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Clinical outcomes
Positive response to pulp vitality tests
2. Radiographic outcomes
Thickening of the dentinal walls of the root canals
Continuation of root development
Closure of the root apex |
Time intervals
At Baseline
1 Month Post Procedure
3 Months Post Procedure
6 Months Post Procedure
1 year Post Procedure |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Goswami M, Sangal A, Saxena A, et al. Clinical
and Radiographic Success of Concentrated Growth Factor and Plateletrich Fibrin for Regenerative Endodontic Procedures in Nonvital
Immature Permanent Teeth: A Systematic Review. J South Asian Assoc
Pediatr Dent 2025;8(3):225–230. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Regenerative Endodontic Treatment (RET) serves as a viable treatment option for the management of non-vital immature teeth and allows for continuation of root development, thickening of the dentinal walls and resolution of any signs and symptoms. The scaffold used in RET contributes significantly to the success of this procedure as it provides a matrix for regeneration of the cells.
|