| CTRI Number |
CTRI/2024/12/077649 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Modern Treatments Amniotic Membranes and PlateletRich Fibrin to Support the Healing and Growth of Young Permanent Teeth |
|
Scientific Title of Study
|
comparative evaluation of human amniotic membrane and platelet-rich fibrin (prf) for apexogenesis in immature non vital permanent teeth: a randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharanya A J |
| Designation |
Junior resident |
| Affiliation |
KING GEORGES MEDICAL UNVERSITY |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
FACULTY OF DENTAL SCIENCES
KING GEORGE MEDICAL UNIVERSITY CHOWK DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
FACULTY OF DENTAL SCIENCES
Lucknow UTTAR PRADESH 226003 India |
| Phone |
8147662400 |
| Fax |
|
| Email |
sharanyajayachandra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Promila verma |
| Designation |
Pofessor and Head |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS , chowk FACULTY OF DENTAL SCIENCES Lucknow UTTAR PRADESH 226003 India |
| Phone |
9415542063 |
| Fax |
|
| Email |
promilarajesh@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Rhythm Bains |
| Designation |
Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
FACULTY OF DENTAL SCIENCES
KING GEORGE MEDICAL UNIVERSITY FACULTY OF DENTAL SCIENCES Lucknow UTTAR PRADESH 226003 India |
| Phone |
9935033439 |
| Fax |
|
| Email |
docrhythm77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, King Georges Medical University,Lucknow,226003,Uttar Pradesh,India |
|
|
Primary Sponsor
|
| Name |
FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
FACULTY OF DENTAL SCIENCES
KING GEORGE MEDICAL UNIVERSITY , CHOWK 226018 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sharanya A J |
Faculty of Dental Sciences, King Georges Medical University |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
FACULTY OF DENTAL SCIENCES
KING GEORGE MEDICAL UNIVERSITY Lucknow UTTAR PRADESH |
8147662400
sharanyajayachandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee , king georges medical university u.p. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K009||Disorder of tooth development, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Human Amniotic Membrane |
During Apexogenesis procedure , after disinfection of canal , Human Amniotic membrane provided by the Tata Memorial Hospital,Parel, Mumbai is filled inside the canal upto middle thirds , and sealed with MTA |
| Comparator Agent |
platelet rich fibrin |
during apexogeneis procedure after disinfecting cacal the canal space upto middle third is filled with platelet rich fibrin,which is made from the 1oml of patients own blood using centrifuge machine at 3000rpm for 10 mins |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patient under the age of 25 years with permanent
immature non-vital teeth will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients above 25 years
Deciduous teeth
Permanent immature teeth that can be treated by a conventional root
canal
treatment/apexifification
Known or suspected current malignancy
History of other metabolic bone diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The clinical outcome will be assessed by checking for symptoms like pain, swelling, or sensitivity, and radiographic outcomes will measure changes in root length and apex width |
3 , 6 , 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Apical width with regeneration of pulp tissue |
12 months |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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)
|
20/01/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pulp tissue in an immature open-apex tooth has a rich blood supply and contains stem cells that possess a great potential to regenerate in response to damage. Pulp necrosis of an immature tooth as a result of caries or trauma could arrest further development of the root, leaving the tooth with thin and weak walls that are prone to fracture. Endodontic treatment of such a tooth is difficult because thin walls do not allow much instrumentation, and the obturation might not provide predictable apical seal due to the large opening of the apex. Regenerative endodontics is a novel modality which involves physiological replacement of the damaged structures of tooth like dentin, root and cells of the pulp-dentin complex. These procedures have not only shown to resolve apical periodontitis but continued root development, thus increasing the thickness and strength of the previously thin and fracture-prone roots. Biological membranes have emerged as a promising tool for regenerative endodontics. These membranes are made of biocompatible materials that can create a barrier or scaffold that supports tissue regeneration and growth. Recently researched tissue engineering materials like platelet-rich fibrin (PRF), platelet-rich plasma (PRP), collagen, give promising results in regenerative endodontics.One such biologically/naturally derived tissue is the Human amniotic membrane (HAM) which has been utilized in the medical field since 1900. The presence of collagen, elastin, laminin and fibronectin makes this membrane an excellent scaffold in tissue engineering. HAM is biologically active due to the presence of growth factors (GF) that aids cell migration and facilitates wound healing.HAM in endodontic procedures, such as pulp capping and periapical surgery, have shown encouraging results. Considering the regenerative potential of HAM, this study has been designed with the aim to evaluate the efficacy of Amniotic membrane as scaffold for regenerative endodontics will be compared to PRF regarding percentage change in apical width and root length. AIMS AND OBJECTIVES: To assess the clinical and radiographic outcomes when using human Amniotic membrane for apexogenesis in immature nonvital permanent teeth. To compare the efficacy of human Amniotic membrane as scaffold in apexogenesis of immature nonvital permanent teeth as compared to PRF
MATERIALS AND METHODS: The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow, in collaboration with Department of Paediatric and preventive Dentistry, Faculty of Dental Science, King George’s Medical University, Lucknow. The study will be conducted only after getting clearance from the Institutional Ethical Committee and registration in CTRI. Suitable subjects will be selected from the department of Conservative Dentistry & Endodontics and Paediatric & Preventive Dentistry and will be randomly divided into two groups namely Platelet-rich fibrin group and human Amniotic Membrane group. This study includes a structured approach to evaluate the clinical and radiographic outcomes of the treatment and compare with baseline parameters over a specified follow-up period. The trial aims to assess the efficacy and safety of the procedure and the use of the amniotic membrane as a scaffold material in dental regenerative therapy. The data obtained will be statistically analyzed. Any changes deemed in the interest of the study will be done accordingly. |