| CTRI Number |
CTRI/2019/03/018162 [Registered on: 19/03/2019] Trial Registered Prospectively |
| Last Modified On: |
15/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Stem Cell Therapy
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison Of Single Vs Multiple visit Regeneration Therapy, on different platforms. |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation Of Single visit with Multiple visit Regeneration Therapy using, Platelet Rich Fibrin, Collagen, and Collagen-Hydroxyapatite, as a Scaffold. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neelam Mittal |
| Designation |
Dean & Head, Operative and Consevative Dentistry Department |
| Affiliation |
Faculty Of Dental Sciences, IMS,BHU |
| Address |
Operative and Conservative Dentistry Department, 3rd Floor, Room no.6
Faculty of Dental Sciences, Trauma Center, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415203360 |
| Fax |
|
| Email |
dr.neelammittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun kumar |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty of Dental Sciences,BHU |
| Address |
Operative and Conservative Dentistry Department, 3rd Floor, Room no.6
Faculty of Dental Sciences, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8468836241 |
| Fax |
|
| Email |
dentarunkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tarun kumar |
| Designation |
Academic Junior Resident |
| Affiliation |
Faculty of Dental Sciences,BHU |
| Address |
Operative and Conservative Dentistry Department, 3rd Floor, Room no.6
Faculty of Dental Sciences, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8468836241 |
| Fax |
|
| Email |
dentarunkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tarun Kumar |
| Address |
Operative and Conservative Department, 3rd Floor, Room no.6, Faculty of Dental Sciences, BHU, Varanasi |
| Type of Sponsor |
Other [Self] |
|
|
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 Neelam Mittal |
Faculty Of Dental Sciences, IMS, BHU |
Operative and Conservative Dentistry Department, 3rd Floor, Room no.6
Varanasi
UTTAR PRADESH |
9415203360
dr.neelammittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee,IMS-BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Necrotic immature permanent asymptomatic teeth, Negative response to hot and cold pulp sensitivity tests, presence of enough coronal structures, No prior endodontic treatment of involved tooth. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multiple Visit Regeneration Therapy |
Initially access opening will be made under rubber dam isolation. Minimum filing was done followed by copious irrigation with sterile Saline and 1.5% sodium hypochlorite. After canals were dried with sterile paper points, infection will be then controlled with double antibiotic paste introduced into the canal system for 2-4 weeks. There after antibiotic paste was removed carefully. 17% EDTA used as a final irrigation solution. Bleeding is then induced by irritating periapical tissue using sterile #20k file. A tight cotton will be then inserted 3-4mm into the canal and kept there for 15minutes for formation of clot. Different Sccafolds then introduced into the root canal system. Access opening will then sealed with biodentin, extending 3mm into the root canal directly over the clot. GIC was done as the final restoration. |
| Intervention |
Single Visit Regeneration Therapy |
Initially access opening will be made under rubber dam isolation. Minimum filing was done followed by copious irrigation with sterile Saline and 1.5% sodium hypochlorite. After canals were dried with sterile paper points, 17% EDTA used as a final irrigation solution. Bleeding is then induced by irritating periapical tissue using sterile #20k file. A tight cotton will be then inserted 3-4mm into the canal and kept there for 15minutes for formation of clot. Different Sccafolds then introduced into the root canal system. Access opening will then sealed with biodentin, extending 3mm into the root canal directly over the clot. GIC was done as the final restoration. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Necrotic immature asymptomatic permanent teeth, Negative response to hot and cold pulp sensitvity tests, Presence of enough coronal structure for rubber dam isolation, No prior endodontic treatment of involved tooth. |
|
| ExclusionCriteria |
| Details |
Patients with medical conditions like cardiac problems, Pregnant patients, Diabetic patients, Patients having Bleeding tendecies,HIV positive patients, Hepatitis-B positive patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inducing root apex formation with single visit to multiple visit regenrative therapy, in a necrotic and asymtomatic immature permanent teeth, devoid of any periapical pathology, with incompletly devloped roots using scaffolds and comparison between them. |
1month, 3months, 6months, 12months. Tooth remain asymptomatic, Increase in the Dentin thickness, Increse on root length, Increase in crown root ratio
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing Of periapical areas with decrease in radiolucent spaces. Decreased chances of re-infection of same tooth, because of the formation of pulp like tissue within the canal system. |
1month, 3months, 6months, 12months.
Healing of periapical areas.
Formation of pulp like tissue within canal system.
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
If the pulp tissue of a young tooth is damaged by trauma or by caries to the extent that irreversible pulpitis with significant pulp necrosis is present with or without involvement of periapical area, the physiological development of root is compromised. The consequences of arrested root devlopment are, poor crown root ratio, root with very thin walls, and an open apex, which leads to fracture of tooth. This study is aimed at inducing root apex formation with single visit to multiple visit regenerative therapy, in a necrotic and asymptomatic immature permanent teeth, with incompletely developed roots using scaffolds and comparison between them. Revascularization was introduced by Ostby in 1961 and reintroduced in 1966 by rule and winter. It is a biologically based treatment regimen that offers, potential for continuous hard tissue formation in young permanent tooth with necrotic root canal system in addition to incompletely developed root. Regenerative endodontics are based on 3 core principles of tissue engineering. 1.Appropriate source of stem/progenitor cells 2.Growth factors that are capable of promoting stem cell differentiation. 3.Appropriate scaffolds for the regulation of cell differentiation. Hertwig’s epithelial root sheath cells or cell rests of Mallasez are sufficiently resistence to peri-apical infections and stimulate various stem cells like stem cells from apical papilla (SCAP),periodontal ligament,bone marrow, and multipotent stem cells, under the effect of growth factors like platelet derived growth factor,vasculo-endothelial growth factor,transforming growth factor-beta, to form odontoblasts. Scaffold will provide a framework for cell growth and differntiation at a local site. A scaffold should be porous (to allow for the placement of cells and growth factors),biocompatible with host tissues and biodegradable. Natural scaffolds (PRF,collagen,collagen-hydroxyapetite) offer good biocompatiblity and bioactivity. The development of normal sterile granulation tissue within root canal is thought to aid in revascularization and stimulation of cementoblasts and undifferentiated mesenchymal cells at peri-apex leads to deposition of calcific material at apex as well as on lateral dentinal walls |